This readme file was generated on 2022-12-12 by Patrick Manser. ################################# ###### GENERAL INFORMATION: ##### ################################# Title of Dataset: Data for Project 'Feasibility, Usability and Acceptance of a Newly Developed Exergame-Based Training Concept for Older Adults with Mild Neurocognitive Disorder - A Pilot Randomized Controlled Trial' Trial Registration: Clinicaltrials.gov (NCT04996654; date of registration: 11 July 2021) First Author and Contact Person Information: Name: Patrick Manser ORCID: 0000-0003-3300-6524 Institution: ETH Zurich Address: Leopold-Ruzicka-Weg 4 | 8093 Zurich | Switzerland Email: patrick.manser@hest.ethz.ch Principal Investigator Information: Name: Prof. Dr. Eling D. de Bruin ORCID: 0000-0002-6542-7385 Institution: ETH Zurich Address: Leopold-Ruzicka-Weg 4 | 8093 Zurich | Switzerland Email: eling.debruin@hest.ethz.ch Date of data collection: Between 2021-07-12 and 2022-06-21 Geographic location of data collection: ETH Zürich (Hönggerberg), Zürich, Switzerland Information about funding sources that supported the collection of the data: This research was funded by Synapsis Foundation - Dementia Research Switzerland (Grant No.: 2019-PI06) and the ‘Gebauer Stiftung’. ################################# ## SHARING/ACCESS INFORMATION: ## ################################# Licenses/restrictions placed on the data: Creative Commons Attribution 4.0 International Links to publications that cite or use the data: This dataset belongs to the manuscript 'Feasibility, Usability and Acceptance of a Newly Developed Exergame-Based Training Concept for Older Adults with Mild Neurocognitive Disorder - A Pilot Randomized Controlled Trial'. At the time of publication of this dataset, the manuscript was in preparation. In case of specific questions about the dataset, please contact patrick.manser@hest.ethz.ch. Links to other publicly accessible locations of the data: N/A Links/relationships to ancillary data sets: N/A Was data derived from another source? If yes, list source(s): N/A Recommended citation for this dataset: Manser, P., Poikonen, H., de Bruin, E. (2022). Data for Project 'Feasibility, Usability and Acceptance of a Newly Developed Exergame-Based Training Concept for Older Adults with Mild Neurocognitive Disorder - A Pilot Randomized Controlled Trial' [Data set]. Zenodo. https://doi.org/10.5281/zenodo.7428378 ################################# ##### DATA & FILE OVERVIEW: ##### ################################# File List: - 1_Data_Primary-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx (created on 2022-06-21) = original and complete data set for all primary outcomes - 2_Data_Secondary-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx (created on 2022-06-21) = original and complete data set for all secondary outcomes - 3_Data_Other-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx (created on 2022-06-21) = original and complete data set for all other outcomes (i.e. baseline factors (demographic data, type of usual care interventions) and training heart rate) - 4_HRV-and-EEG_raw-and-processed-data.zip (created on 2022-09-16) = folder including the raw and processed HRV and EEG data for all participants and measurements Relationship between files, if important: N/A Additional related data collected that was not included in the current data package: The Project 'Feasibility, Usability and Acceptance of a Newly Developed Exergame-Based Training Concept for Older Adults with Mild Neurocognitive Disorder - A Pilot Randomized Controlled Trial' also included qualitative data collection and analysis. In particular, perceived usefulness if the training was evaluated after the last supervised training session on basis of individual patient-interviews, organized as semi-structured in-depth interviews along an interview guide (see https://clinicaltrials.gov/ct2/show/NCT04996654). Data of these semi-structured in-depth interviews is available from the corresponding author, Patrick Manser (patrick.manser@hestr.ethz.ch), upon reasonable request. Are there multiple versions of the dataset? If yes, name of file(s) that was updated: N/A ################################# ## METHODOLOGICAL INFORMATION: ## ################################# Description of methods used for collection/generation of data: This dataset belongs to the manuscript manuscript 'Feasibility, Usability and Acceptance of a Newly Developed Exergame-Based Training Concept for Older Adults with Mild Neurocognitive Disorder - A Pilot Randomized Controlled Trial'. The study design and the methods of data collection are reported in this manuscript. At the time of publication of this dataset, the manuscript was in preparation. In case of specific questions about the dataset or the manuscript, please contact patrick.manser@hest.ethz.ch. In short, a pilot randomized controlled trial (RCT) with an allocation ration of 2 : 1 (i.e., intervention : control) was conducted. The control group proceeded with usual care. The intervention group performed a twelve-week training intervention according to the ‘Brain-IT’ training concept (https://doi.org/10.3389/fnagi.2021.734012) in addition to usual care. Feasibility and usability outcomes were analyzed using descriptive statistics. User acceptance was analyzed qualitatively and using Friedman analysis of variance (ANOVA). Methods for processing the data: The data files '1_Data_Primary-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx', '2_Data_Secondary-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx', and '3_Data_Other-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx' were created by directly downloading the records from the electronic case report files used for data collection (= source data). The data file includes raw data and processed data (e.g. total and/or composite scores for questionnaires that were computed directly in the electronic case report forms implemented in the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands) through corresponding built-in mathematical formulae programmed prior to data collection). The tabs 'Feasibility - Recruitment', 'Feasibility - Adherence', 'Feasibility - Compliance', and 'Feasibility - Attrition' were added to the data file '1_Data_Primary-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx' and were continuously generated throughout the study by the study investigators. Instrument- or software-specific information needed to interpret the data: N/A Standards and calibration information, if appropriate: N/A Environmental/experimental conditions: This dataset belongs to the manuscript manuscript 'Feasibility, Usability and Acceptance of a Newly Developed Exergame-Based Training Concept for Older Adults with Mild Neurocognitive Disorder - A Pilot Randomized Controlled Trial'. The study design and the methods of data collection are reported in this manuscript. At the time of publication of this dataset, the manuscript was in preparation. In case of specific questions about the dataset or the manuscript, please contact patrick.manser@hest.ethz.ch. In short, a pilot randomized controlled trial (RCT) with an allocation ration of 2 : 1 (i.e., intervention : control) was conducted. The control group proceeded with usual care. The intervention group performed a twelve-week training intervention according to the ‘Brain-IT’ training concept (https://doi.org/10.3389/fnagi.2021.734012) in addition to usual care. Feasibility and usability outcomes were analyzed using descriptive statistics. User acceptance was analyzed qualitatively and using Friedman analysis of variance (ANOVA). Describe any quality-assurance procedures performed on the data: All data entries were cross-checked by a second study investigator before data was exported for analysis. People involved with sample collection, processing, analysis and/or submission: Patrick Manser, Hanna Poikonen, and Eling D. de Bruin ################################# ## DATA-SPECIFIC INFORMATION: ### ################################# ########### DATAFILE 1 ########## File: '1_Data_Primary-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx' (created on 2022-06-21) = original and complete data set for all primary outcomes Overview: Tab 1: Feasibility - Recruitment => recruitment protocol including the decisions for study participation for each contacted patient Tab 2: Feasibility - Adherence => adherence protocol including absolute and relative adherence rates for each participant in the intervention group as well as reasons for non-adherence and number of supervised training sessions Tab 3: Feasibility - Compliance => compliance protocol including absolute and relative compliance rates for each participant in the intervention group as well as reasons for non-compliance Tab 4: Feasibility - Attrition => attrition protocol including participant status, number and reasons for dropouts Tab 5: Feasibility - Usability - SUS => raw and processed data for the System Usability Scale (SUS) Tab 6: Feasibility - Acceptance - Enjoyment (EEQ-G) => raw and processed data for the German Version of the Exergame Enjoyment Scale (EEQ-G) Tab 7: Feasibility - Acceptance - Motivation (BREQ) => raw and processed data for the Behavioral Regulation in Exercise Questionnaire (BREQ) Number of variables: Tab 1: Feasibility - Recruitment: 7 Tab 2: Feasibility - Adherence: 18 Tab 3: Feasibility - Compliance: 17 Tab 4: Feasibility - Attrition: 4 Tab 5: Feasibility - Usability: 13 Tab 6: Feasibility - Acceptance - Enjoyment (EEQ-G): 127 Tab 7: Feasibility - Acceptance - Motivation (BREQ): 187 Number of cases/rows: Tab 1: Feasibility - Recruitment: 51 Tab 2: Feasibility - Adherence: 10 Tab 3: Feasibility - Compliance: 10 Tab 4: Feasibility - Attrition: 10 Tab 5: Feasibility - Usability: 10 Tab 6: Feasibility - Acceptance - Enjoyment (EEQ-G): 10 Tab 7: Feasibility - Acceptance - Motivation (BREQ): 10 Variable List: Tab 1: Feasibility - Recruitment: - Screening Number [] = screening number of patients contacted by one of the trained investigators of the study team - first contacted on [YYYY-MM-DD] = date on which patients were first contacted by one of the trained investigators of the study team - Study Participation [yes, no; with reasons] = decisions about study participation for each patient, with reasons. - included on [YYYY-MM-DD] = date on which patients provided written informed consent, were screened on eligibility, and were included into the study - Participant Number [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) - Category [mNCD, sMCI] = categorization of study participants into: (1 = mNCD) clinical diagnosis of ‘mild neurocognitive disorder’ according to International Classification of Diseases 11th Revision (ICD-XI) or the latest Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5®)9); OR (2 = sMCI) patients screened for mild cognitive impairment (sMCI) according to the following criteria: (a) informant (i.e., healthcare professionals)-based suspicion of mild cognitive impairment (MCI) confirmed by (b) an objective screening of MCI based on the German Version of the Quick Mild Cognitive Impairment Screen (Qmci) with (b1) a recommended cut-off score for cognitive impairment (MCI or dementia) of < 62/100, while (b2) not falling below the cut-off score for dementia (i.e., < 45/100), while (c) activities of daily living remain intact (judged by the referring healthcare professionals). - Main Clinical Subtype [] = main clinical subtype classification of study participants (i.e. mNCD due to Alzheimer’s Disease, mild Frontotemporal NCD, mild vascular NCD, or mNCD with Lewy Bodies) Tab 2: Feasibility - Adherence: - This tab contains a detailled adherence protocol including variables for absolute and relative adherence rates for each participant in the intervention group as well as for reasons for non-adherence and number of supervised training sessions. The main outcome variable was adherence rate [%] = number of training sessions attended / total number of training sessions offered; calculated as the average of each participants weekly adherence with a maximum of 100 %. Reasons for non-adherence were classified according to the following codes: (1) for time reasons, (2) due to technical problems, (3) forgot to train, (4) due to comprehension problems, (5) lack of motivation, (6) interruption of training due to adverse events, (7) other reasons, and (8) unknown. Tab 3: Feasibility - Compliance: - This tab contains a detailled compliance protocol including variables for absolute and relative compliance rates for each participant in the intervention group as well as for reasons for non-compliance. The main outcome variable was compliance rate (COMP) [%] = training duration attended [min] / total training duration offered [min]); calculated as the average of each participants weekly compliance with a maximum of 100 %. Reasons for non-compliance were classified according to the following codes: (1) accidentally stopped the training by staying on the back plate of the exergame device for too long, (2) due to technical problems, and (3) unknown. Tab 4: Feasibility - Attrition: - Participant Number [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) - Status [1 = training completed, 0 = dropout] = participant status, categorized into 1 = training completed, and 0 = dropout. - Timepoint of droputs [week of intervention] = timepoint of participants' dropout - Reason for dropout [] = explanation of the reasons(s) for dropout(s) Tab 5: Feasibility - Usability: - Participant Number [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) - SUS_Qn [] = SUS item ratings for items n (n = items 1 - 10) - SUS_average_points [] = average score for SUS item ratings - SUS_total_score [] = SUS total score Tab 6: Feasibility - Acceptance - Enjoyment (EEQ-G): - Participant Number [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) - EEQ_qn_wm [] = EEQ-G item scores for items n (n = items 1 - 20) and training weeks m (m = weeks 2 - 12) - EEQ_total_score_wm [] = EEQ-G total scores for training weeks m (m = weeks 2 - 12) Tab 7: Feasibility - Acceptance - Motivation (BREQ): - Participant Number [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) - BREQ_wm_qn [] = BREQ item scores for items n (n = items 1 - 24) and training weeks m (m = weeks 1 - 11) - BREQ_amotivation_wm [] = subscore 'external motivation' of the BREQ for training weeks m (m = weeks 1 - 11) - BREQ_external_wm [] = subscore 'external motivation' of the BREQ for training weeks m (m = weeks 1 - 11) - BREQ_introjected_wm [] = subscore 'introjected motivation' of the BREQ for training weeks m (m = weeks 1 - 11) - BREQ_identified_wm [] = subscore 'identified motivation' of the BREQ for training weeks m (m = weeks 1 - 11) - BREQ_integrated_wm [] = subscore 'integrated motivation' of the BREQ for training weeks m (m = weeks 1 - 11) - BREQ_intrinsic_wm [] = subscore 'intrinsic motivation' of the BREQ for training weeks m (m = weeks 1 - 11) - BREQ_SDI_wm [] = Self Determination Index (SDI) for training weeks m (m = weeks 1 - 11) Missing data codes: -95 = measurement failed -96 = not applicable -97 = not asked/evaluated -98 = asked but unknown -99 = measurement not done (e.g. in case of droputs after withdrawal from study) Specialized formats or other abbreviations used: N/A ########### DATAFILE 2 ########## File: '2_Data_Secondary-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx' (created on 2022-06-21) = original and complete data set for all secondary outcomes Number of variables: 288 Number of cases/rows: 16 Variable List: 1. Study Participants: - pat_ID [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) 2. Group: - pat_allocation [Exergame, Usual Care] = group allocation according to a computer generated variable block randomization (i.e., block sizes = 3, 6) with a 2 : 1 allocation ratio (intervention : control) stratified by sex using a validated variable block randomization model implemented in the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands) 3. Data of PRE-Measurements: 3.1 Resting vagally-mediated Heart Rate Variability (vm-HRV) - beat_corr_PRE [0 = no, 1 = yes] = categorial variable whether the validated automatic beat correction algorithm and noise handling provided by the Kubios HRV Premium (Kubios Oy, Kuopio, Finland, version 3.4) software corrected for artifact and/or ectopic beats - LQD_rest_PRE [% beats corrected] = percentage of beats corrected by the validated automatic beat correction algorithm - mRR_rest_PRE [ms] = mean R-R time intervals (mRR) - RMSSD_rest_PRE [] = root mean square of successive RR interval differences (RMSSD) - pNN50_rest_PRE [%] = percentage of successive RR intervals that differ by more than 50 ms (pNN50) - HF_rest_PRE [ms^2] = absolute power of the high-frequency (0.15 – 0.4 Hz; HF) band - HFnu_rest_PRE n.u. (normalized unit)] = relative power of HF (in normal units; HF [n.u.] = HF [ms^2] / (total power [ms^2] – very low frequency (0.00 – 0.04 Hz [ms^2])) - SD1_rest_PRE [ms] = Poincaré plot standard deviation perpendicular to the line of identity (SD1) - PNSIndex_rest_PRE [] = parasympathetic nervous system tone index (PNS-Index) 3.2 Quick Mild Cognitive Impairment Screen (Qmci) - Qmci_subscore_orientation_PRE [] = item score for subtest 'orientation' - Qmci_subscore_registration_PRE [] = item score for subtest 'registration' - Qmci_subscore_clock_PRE [] = item score for subtest 'clock drawing' - Qmci_subscore_recall_PRE [] = item score for subtest 'delayed recall' - Qmci_subscore_fluency_PRE [] = item score for subtest 'verbal fluency' - Qmci_subscore_memory_PRE [] = item score for subtest 'logical memory' - Qmci_score_tot_PRE [] = total score of the Qmci 3.3 Subtest ‘Alertness’ of the Test of Attentional Performance (TAP-Alertness) - TAP_Alertness_reactiontime_A1_PRE [ms] = median reaction time for condition 'A1' - TAP_Alertness_stdw_reactiontime_A1_PRE [ms] = standard deviation of reaction times for condition 'A1' - TAP_Alertness_reactiontime_B1_PRE [ms] = median reaction time for condition 'B1' - TAP_Alertness_stdw_reactiontime_B1_PRE [ms] = standard deviation of reaction times for condition 'B1' - TAP_Alertness_reactiontime_B2_PRE [ms] = median reaction time for condition 'B2' - TAP_Alertness_stdw_reactiontime_B2_PRE [ms] = standard deviation of reaction times for condition 'B2' - TAP_Alertness_reactiontime_A2_PRE [ms] = median reaction time for condition 'A2' - TAP_Alertness_stdw_reactiontime_A2_PRE [ms] = standard deviation of reaction times for condition 'A2' - TAP_Alertness_reactiontime_A_PRE [ms] = mean reaction time for condition 'A' - TAP_Alertness_variance_A_PRE [ms] = standard deviation of reaction times for condition 'A' - TAP_Alertness_reactiontime_B_PRE [ms] = mean reaction time for condition 'B' - TAP_Alertness_variance_B_PRE [ms] = standard deviation of reaction times for condition 'B' 3.4 Subtest ‘Go-NoGo’ of the Test of Attentional Performance (TAP-Go/NoGo) - TAP_GO_NoGo_reactiontime_PRE [ms] = median reaction time - TAP_GO_NoGo_stdw_reactiontime_PRE [ms] = standard deviation of reaction times - TAP_GO_NoGo_errors_PRE [] = number of errors - TAP_GO_NoGo_omissions_PRE [] = number of omissions 3.5 Subtest ‘Incompatibility’ of the Test of Attentional Performance (TAP-Incompatibility) - TAP_Incompatibiliy_reactiontime_comp_PRE [ms] = median reaction time for condition 'compatible' - TAP_Incompatibiliy_stdw_reactiontime_comp_PRE [ms] = standard deviation of reaction times for condition 'compatible' - TAP_Incompatibility_errors_comp_PRE [] = number of errors in condition 'compatible' - TAP_Incompatibiliy_reactiontime_incomp_PRE [ms] = median reaction time for condition 'incompatible' - TAP_Incompatibiliy_stdw_reactiontime_incomp_PRE [ms] = standard deviation of reaction times for condition 'incompatible' - TAP_Incompatibility_errors_incomp_PRE [] = number of errors in condition 'incompatible' 3.6 Subtest ‘logical memory’ of the Wechsler Memory Scale – fourth edition (WMS-IV-LM) - WMS_LM1_total_score_PRE [] = score part 1 (immediate recall) - WMS_timediff_PRE [min] = time difference between Parts 1 and 2 - WMS_LM2_total_score_PRE [] = score part 2 (delayed recall) - WMS_LM2_total_recognition_score_PRE [] = Score Part 2 (recognition) 3.7 Quality of Life-Alzheimer’s Disease (QoL-AD) - QOL_AD_subscore_n_PRE [] = item score for question n (n = questions 1 - 13) - QOL_AD_tot_score_PRE [] = total score of the QoL-AD 3.8 Gait Analysis - Gait_speed_PRE [m/s] = mean gait speed at preferred walking speed - Gait_speed_Std_PRE [m/s] = standard deviation of gait speed at preferred walking speed - Gait_stride_duration_right_PRE [s] = mean stride duration right - Gait_stride_duration_Std_right_PRE [s] = standard deviation of stride duration right - Gait_stride_duration_left_PRE [s] = mean stride duration left - Gait_stride_duration_Std_left_PRE [s] = standard deviation of stride duration left - Gait_stride_duration_PRE [s] = mean stride duration - Gait_stride_duration_Std_PRE [s] = standard deviation of stride duration - Gait_stridelength_right_PRE [m] = mean stride length right - Gait_stridelength_Std_right_PRE [m] = standard deviation of stride length right - Gait_stridelength_left_PRE [m] = mean stride length left - Gait_stridelength_Std_left_PRE [m] = standard deviation of stride length left - Gait_stridelength_PRE [m] = mean stride length - Gait_stridelength_Std_PRE [m] = standard deviation of stride length - Gait_stance_right_PRE [% stride duration] = mean stance phase duration right - Gait_stance_Std_right_PRE [% stride duration] = standard deviation of stance phase duration right - Gait_stance_left_PRE [% stride duration] = mean stance phase duration left - Gait_stance_Std_left_PRE [% stride duration] = standard deviation of stance phase duration left - Gait_stance_PRE [% stride duration] = mean stance phase duration - Gait_stance_Std_PRE [% stride duration] = standard deviation of stance phase duration - Gait_swing_right_PRE [% stride duration] = mean swing phase duration right - Gait_swing_Std_right_PRE [% stride duration] = standard deviation of swing phase duration right - Gait_swing_left_PRE [% stride duration] = mean swing phase duration left - Gait_swing_Std_left_PRE Gait_swing_PRE [% stride duration] = standard deviation of swing phase duration left - Gait_swing_Std_PRE [% stride duration] = mean swing phase duration - Gait_double_support_right_PRE [%] = mean double support time right - Gait_double_support_Std_right_PRE [%] = standard deviation of double support time right - Gait_double_support_left_PRE [%] = mean double support time left - Gait_double_support_Std_left_PRE [%] = standard deviation of double support time left - Gait_double_support_PRE [%] = mean double support time - Gait_double_support_Std_PRE [%] = standard deviation of double support time - Gait_single_support_right_PRE [%] = mean single support time right - Gait_single_support_Std_right_PRE [%] = standard deviation of single support time right - Gait_single_support_left_PRE [%] = mean single support time left - Gait_single_support_Std_left_PRE [%] = standard deviation of single support time left - Gait_single_support_PRE [%] = mean single support time - Gait_single_support_Std_PRE [%] = standard deviation of single support time - Gait_strides_right_PRE [] = number of strides included in the analysis; right - Gait_strides_left_PRE [] = number of strides included in the analysis; left - Gait_strides_PRE [] = mean number of strides included in the analysis 3.9 Depression, Anxiety and Stress Scale-21 (DASS-21) - DASS_21_subscore_n_PRE [] = item score for question n (n = questions 1 - 21) - DASS_21_depression_tot_score_PRE [] = composite score 'depression' - DASS_21_anxiety_tot_score_PRE [] = composite score 'anxiety' - DASS_21_stress_tot_score_PRE [] = composite score 'stress' 3.10 computerized Trail Making Test (TMT) - PEBL_TMT_A_time_PRE [s] = completion time for TMT-A - PEBL_TMT_A_numberrors_PRE [] = number of errors TMT-A - PEBL_TMT_B_time_PRE [s] = completion time for TMT-B - PEBL_TMT_B_numberrors_PRE [] = number of errors TMT-B 3.11 computerized Mental Rotation Task (MRT) - PEBL_MRT_reactiontime_PRE [ms] = median reaction time of correct answered trials - PEBL_MRT_performance_PRE [] = performance (number of correct answered trials) 3.12 computerized Digit Span Forwanrd and Backward (DSF/DSB) - PEBL_DSF_score_PRE [] = total point score DSF - PEBL_DSF_maxspan_PRE [spanlength] = maximum span (length of the longest correctly repeated digit sequence) DSF - PEBL_DSB_score_PRE [] = total point score DSB - PEBL_DSB_maxspan_PRE [spanlength] = maximum span (length of the longest correctly repeated digit sequence) DSB 3.13 HOTAP picture-sorting test part A (HOTAP-A) - HOTAP_A_score_PRE [] = sum of points - HOTAP_A_time_PRE [s] = time needed to arrange the cards - HOTAP_A_combiscore_PRE [points/min] = combi score (calculated by the sum of points divided by the time needed to arrange the cards) 3.14 Resting-state Cortical Activity - EEG_amplitudepower_beta_Cz_PRE [uV^2/Hz] = amplitude power of the beta (13 – 30 Hz) frequency band, electrode 'central (Cz)' - EEG_amplitudepower_theta_T7_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'left temporal (T7)' - EEG_amplitudepower_theta_T8_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'right temporal (T8)' - EEG_amplitudepower_theta_FT7_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'left frontotemporal (FT7)' - EEG_amplitudepower_theta_FT8_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'right frontotemporal (FT8)' - EEG_phasesynchrony_alpha_FP2C4_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs Fp2-C4 - EEG_phasesynchrony_alpha_F7T6_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs F7-T6 - EEG_phasesynchrony_alpha_T3T6_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs T3-T6 - EEG_phasesynchrony_alpha_T5T6_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs T5-T6 4. Data of POST-Measurements: 4.1 Resting vagally-mediated Heart Rate Variability (vm-HRV) - beat_corr_PRE [0 = no, 1 = yes] = categorial variable whether the validated automatic beat correction algorithm and noise handling provided by the Kubios HRV Premium (Kubios Oy, Kuopio, Finland, version 3.4) software corrected for artifact and/or ectopic beats - LQD_rest_PRE [% beats corrected] = percentage of beats corrected by the validated automatic beat correction algorithm - mRR_rest_PRE [ms] = mean R-R time intervals (mRR) - RMSSD_rest_PRE [] = root mean square of successive RR interval differences (RMSSD) - pNN50_rest_PRE [%] = percentage of successive RR intervals that differ by more than 50 ms (pNN50) - HF_rest_PRE [ms^2] = absolute power of the high-frequency (0.15 – 0.4 Hz; HF) band - HFnu_rest_PRE n.u. (normalized unit)] = relative power of HF (in normal units; HF [n.u.] = HF [ms^2] / (total power [ms^2] – very low frequency (0.00 – 0.04 Hz [ms^2])) - SD1_rest_PRE [ms] = Poincaré plot standard deviation perpendicular to the line of identity (SD1) - PNSIndex_rest_PRE [] = parasympathetic nervous system tone index (PNS-Index) 4.2 Quick Mild Cognitive Impairment Screen (Qmci) - Qmci_subscore_orientation_PRE [] = item score for subtest 'orientation' - Qmci_subscore_registration_PRE [] = item score for subtest 'registration' - Qmci_subscore_clock_PRE [] = item score for subtest 'clock drawing' - Qmci_subscore_recall_PRE [] = item score for subtest 'delayed recall' - Qmci_subscore_fluency_PRE [] = item score for subtest 'verbal fluency' - Qmci_subscore_memory_PRE [] = item score for subtest 'logical memory' - Qmci_score_tot_PRE [] = total score of the Qmci 4.3 Subtest ‘Alertness’ of the Test of Attentional Performance (TAP-Alertness) - TAP_Alertness_reactiontime_A1_PRE [ms] = median reaction time for condition 'A1' - TAP_Alertness_stdw_reactiontime_A1_PRE [ms] = standard deviation of reaction times for condition 'A1' - TAP_Alertness_reactiontime_B1_PRE [ms] = median reaction time for condition 'B1' - TAP_Alertness_stdw_reactiontime_B1_PRE [ms] = standard deviation of reaction times for condition 'B1' - TAP_Alertness_reactiontime_B2_PRE [ms] = median reaction time for condition 'B2' - TAP_Alertness_stdw_reactiontime_B2_PRE [ms] = standard deviation of reaction times for condition 'B2' - TAP_Alertness_reactiontime_A2_PRE [ms] = median reaction time for condition 'A2' - TAP_Alertness_stdw_reactiontime_A2_PRE [ms] = standard deviation of reaction times for condition 'A2' - TAP_Alertness_reactiontime_A_PRE [ms] = mean reaction time for condition 'A' - TAP_Alertness_variance_A_PRE [ms] = standard deviation of reaction times for condition 'A' - TAP_Alertness_reactiontime_B_PRE [ms] = mean reaction time for condition 'B' - TAP_Alertness_variance_B_PRE [ms] = standard deviation of reaction times for condition 'B' 4.4 Subtest ‘Go-NoGo’ of the Test of Attentional Performance (TAP-Go/NoGo) - TAP_GO_NoGo_reactiontime_PRE [ms] = median reaction time - TAP_GO_NoGo_stdw_reactiontime_PRE [ms] = standard deviation of reaction times - TAP_GO_NoGo_errors_PRE [] = number of errors - TAP_GO_NoGo_omissions_PRE [] = number of omissions 4.5 Subtest ‘Incompatibility’ of the Test of Attentional Performance (TAP-Incompatibility) - TAP_Incompatibiliy_reactiontime_comp_PRE [ms] = median reaction time for condition 'compatible' - TAP_Incompatibiliy_stdw_reactiontime_comp_PRE [ms] = standard deviation of reaction times for condition 'compatible' - TAP_Incompatibility_errors_comp_PRE [] = number of errors in condition 'compatible' - TAP_Incompatibiliy_reactiontime_incomp_PRE [ms] = median reaction time for condition 'incompatible' - TAP_Incompatibiliy_stdw_reactiontime_incomp_PRE [ms] = standard deviation of reaction times for condition 'incompatible' - TAP_Incompatibility_errors_incomp_PRE [] = number of errors in condition 'incompatible' 4.6 Subtest ‘logical memory’ of the Wechsler Memory Scale – fourth edition (WMS-IV-LM) - WMS_LM1_total_score_PRE [] = score part 1 (immediate recall) - WMS_timediff_PRE [min] = time difference between Parts 1 and 2 - WMS_LM2_total_score_PRE [] = score part 2 (delayed recall) - WMS_LM2_total_recognition_score_PRE [] = Score Part 2 (recognition) 4.7 Quality of Life-Alzheimer’s Disease (QoL-AD) - QOL_AD_subscore_n_PRE [] = item score for question n (n = questions 1 - 13) - QOL_AD_tot_score_PRE [] = total score of the QoL-AD 4.8 Gait Analysis - Gait_speed_PRE [m/s] = mean gait speed at preferred walking speed - Gait_speed_Std_PRE [m/s] = standard deviation of gait speed at preferred walking speed - Gait_stride_duration_right_PRE [s] = mean stride duration right - Gait_stride_duration_Std_right_PRE [s] = standard deviation of stride duration right - Gait_stride_duration_left_PRE [s] = mean stride duration left - Gait_stride_duration_Std_left_PRE [s] = standard deviation of stride duration left - Gait_stride_duration_PRE [s] = mean stride duration - Gait_stride_duration_Std_PRE [s] = standard deviation of stride duration - Gait_stridelength_right_PRE [m] = mean stride length right - Gait_stridelength_Std_right_PRE [m] = standard deviation of stride length right - Gait_stridelength_left_PRE [m] = mean stride length left - Gait_stridelength_Std_left_PRE [m] = standard deviation of stride length left - Gait_stridelength_PRE [m] = mean stride length - Gait_stridelength_Std_PRE [m] = standard deviation of stride length - Gait_stance_right_PRE [% stride duration] = mean stance phase duration right - Gait_stance_Std_right_PRE [% stride duration] = standard deviation of stance phase duration right - Gait_stance_left_PRE [% stride duration] = mean stance phase duration left - Gait_stance_Std_left_PRE [% stride duration] = standard deviation of stance phase duration left - Gait_stance_PRE [% stride duration] = mean stance phase duration - Gait_stance_Std_PRE [% stride duration] = standard deviation of stance phase duration - Gait_swing_right_PRE [% stride duration] = mean swing phase duration right - Gait_swing_Std_right_PRE [% stride duration] = standard deviation of swing phase duration right - Gait_swing_left_PRE [% stride duration] = mean swing phase duration left - Gait_swing_Std_left_PRE Gait_swing_PRE [% stride duration] = standard deviation of swing phase duration left - Gait_swing_Std_PRE [% stride duration] = mean swing phase duration - Gait_double_support_right_PRE [%] = mean double support time right - Gait_double_support_Std_right_PRE [%] = standard deviation of double support time right - Gait_double_support_left_PRE [%] = mean double support time left - Gait_double_support_Std_left_PRE [%] = standard deviation of double support time left - Gait_double_support_PRE [%] = mean double support time - Gait_double_support_Std_PRE [%] = standard deviation of double support time - Gait_single_support_right_PRE [%] = mean single support time right - Gait_single_support_Std_right_PRE [%] = standard deviation of single support time right - Gait_single_support_left_PRE [%] = mean single support time left - Gait_single_support_Std_left_PRE [%] = standard deviation of single support time left - Gait_single_support_PRE [%] = mean single support time - Gait_single_support_Std_PRE [%] = standard deviation of single support time - Gait_strides_right_PRE [] = number of strides included in the analysis; right - Gait_strides_left_PRE [] = number of strides included in the analysis; left - Gait_strides_PRE [] = mean number of strides included in the analysis 4.9 Depression, Anxiety and Stress Scale-21 (DASS-21) - DASS_21_subscore_n_PRE [] = item score for question n (n = questions 1 - 21) - DASS_21_depression_tot_score_PRE [] = composite score 'depression' - DASS_21_anxiety_tot_score_PRE [] = composite score 'anxiety' - DASS_21_stress_tot_score_PRE [] = composite score 'stress' 4.10 computerized Trail Making Test (TMT) - PEBL_TMT_A_time_PRE [s] = completion time for TMT-A - PEBL_TMT_A_numberrors_PRE [] = number of errors TMT-A - PEBL_TMT_B_time_PRE [s] = completion time for TMT-B - PEBL_TMT_B_numberrors_PRE [] = number of errors TMT-B 4.11 computerized Mental Rotation Task (MRT) - PEBL_MRT_reactiontime_PRE [ms] = median reaction time of correct answered trials - PEBL_MRT_performance_PRE [] = performance (number of correct answered trials) 4.12 computerized Digit Span Forwanrd and Backward (DSF/DSB) - PEBL_DSF_score_PRE [] = total point score DSF - PEBL_DSF_maxspan_PRE [spanlength] = maximum span (length of the longest correctly repeated digit sequence) DSF - PEBL_DSB_score_PRE [] = total point score DSB - PEBL_DSB_maxspan_PRE [spanlength] = maximum span (length of the longest correctly repeated digit sequence) DSB 4.13 HOTAP picture-sorting test part A (HOTAP-A) - HOTAP_A_score_PRE [] = sum of points - HOTAP_A_time_PRE [s] = time needed to arrange the cards - HOTAP_A_combiscore_PRE [points/min] = combi score (calculated by the sum of points divided by the time needed to arrange the cards) 4.14 Resting-state Cortical Activity - EEG_amplitudepower_beta_Cz_PRE [uV^2/Hz] = amplitude power of the beta (13 – 30 Hz) frequency band, electrode 'central (Cz)' - EEG_amplitudepower_theta_T7_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'left temporal (T7)' - EEG_amplitudepower_theta_T8_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'right temporal (T8)' - EEG_amplitudepower_theta_FT7_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'left frontotemporal (FT7)' - EEG_amplitudepower_theta_FT8_PRE [uV^2/Hz] = amplitude power of the theta (4 – 8 Hz) frequency band, electrode 'right frontotemporal (FT8)' - EEG_phasesynchrony_alpha_FP2C4_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs Fp2-C4 - EEG_phasesynchrony_alpha_F7T6_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs F7-T6 - EEG_phasesynchrony_alpha_T3T6_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs T3-T6 - EEG_phasesynchrony_alpha_T5T6_PRE [] = phase synchrony index γ of alpha (8 – 13 Hz) frequency between electrode pairs T5-T6 Missing data codes: -95 = measurement failed -96 = not applicable -97 = not asked/evaluated -98 = asked but unknown -99 = measurement not done (e.g. in case of droputs after withdrawal from study) Specialized formats or other abbreviations used: N/A ########### DATAFILE 3 ########## File: '3_Data_Other-Outcomes_Brain-IT-Pilot-Feasibility-RCT_for-publication.xlsx' (created on 2022-06-21) = original and complete data set for all other outcomes (i.e. baseline factors (demographic data, type of usual care interventions) and training heart rate) Overview: Tab 1: Baseline Factors => demographic data (including age, sex, height, weight, body mass index (BMI), years of education, physical activity behavior (i.e., time spent in at least moderate level of physical activity per week), medication intake (yes/no), and clinical subtype (i.e., mainly mNCD due to AD, mild Frontotemporal NCD, mNCD with Lewy Bodies, or mild vascular NCD)) as well as information on type of usual care interventions for all study participants. Tab 2: Training Heart Rate => data on heart rate during training for participants in the intervention group, separated by week, training blocks (i.e. blocks 1 - 3), and phase ('facilitation', 'guidance', and 'coherence') Number of variables: Tab 1: Baseline Factors: 13 Tab 2: Training Heart Rate: 109 Number of cases/rows: Tab 1: Baseline Factors: 18 Tab 2: Training Heart Rate: 10 Variable List: Tab 1: Baseline Factors: 1. Study Participants: - pat_ID [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) 2. Group: - pat_allocation [Exergame, Usual Care] = group allocation according to a computer generated variable block randomization (i.e., block sizes = 3, 6) with a 2 : 1 allocation ratio (intervention : control) stratified by sex using a validated variable block randomization model implemented in the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands) 3. Demographic Data: - pat_age [years] = participants' age - pat_sex [0 = female; 1 = male] = participants' sex - pat_education [years] = years of participants' education - pat_height [m] = participants' height - pat_weight [kg] = participants' weight - pat_bmi [kg/m^2] = participants' body mass index - pat_activity [min/week] = participants' time spent in at least moderate level of physical activity per week - pat_medication [0 = none; 1 = yes (regular intake)] = participants' intake of medication - pat_category [mNCD, sMCI] = categorization of study participants into: (1 = mNCD) clinical diagnosis of ‘mild neurocognitive disorder’ according to International Classification of Diseases 11th Revision (ICD-XI) or the latest Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5®)9); OR (2 = sMCI) patients screened for mild cognitive impairment (sMCI) according to the following criteria: (a) informant (i.e., healthcare professionals)-based suspicion of mild cognitive impairment (MCI) confirmed by (b) an objective screening of MCI based on the German Version of the Quick Mild Cognitive Impairment Screen (Qmci) with (b1) a recommended cut-off score for cognitive impairment (MCI or dementia) of < 62/100, while (b2) not falling below the cut-off score for dementia (i.e., < 45/100), while (c) activities of daily living remain intact (judged by the referring healthcare professionals). - pat_clinicalsutype [] = main clinical subtype classification of study participants (i.e. mNCD due to Alzheimer’s Disease, mild Frontotemporal NCD, mild vascular NCD, or mNCD with Lewy Bodies) 4. Type of Usual Care Interventions - pat_usualcare [] = description of details about all structured and/or guided usual care interventions Tab 2: Training Heart Rate: 1. Study Participants: - pat_ID [] = participant number for all included study participants (i.e. an eight-digit random number was generated by the data management system Castor EDC (Ciwit BV, Amsterdam, The Netherlands)) 2. Training Week m (m = weeks 1 - 12) - HR_facilitation_wm_bx (m = training weeks 1 - 12, x = training blocks 1 - 3) [bpm] = heart rate in phase 'facilitation' in training week m (m = training weeks 1 - 12) and block x (x = training blocks 1 - 3) - HR_guidance_wm_bx (m = training weeks 1 - 12, x = training blocks 1 - 3) [bpm] = heart rate in phase 'guidance' in training week m (m = training weeks 1 - 12) and block x (x = training blocks 1 - 3) - HR_coherence_wm_bx (m = training weeks 1 - 12, x = training blocks 1 - 3) [bpm] = heart rate in phase 'coherence' in training week m (m = training weeks 1 - 12) and block x (x = training blocks 1 - 3) Missing data codes: -95 = measurement failed -96 = not applicable -97 = not asked/evaluated -98 = asked but unknown -99 = measurement not done (e.g. in case of droputs after withdrawal from study) Specialized formats or other abbreviations used: N/A ########### DATAFILE 4 ########## File: '4_HRV-and-EEG_raw-and-processed-data.zip' (created on 2022-09-16) = folder including the raw and processed HRV and EEG data for all participants and measurements Overview: This folder contains the raw and processed heart rate variability (HRV) and electroencephalography (EEG) data for all participants and measurements. It is structured as follows: (1) HRV-and-EEG_raw-and-processed-data (1.1) EEG (1.1.1) PRE-Measurements = folder containing all raw and preprocessed datafiles for the EEG resting awake state measurement at the PRE-Measurement (1.1.2) POST-Measurements = folder containing all raw and preprocessed datafiles for the EEG resting awake state measurement at the POST-Measurement (1.2) HRV (1.2.1) PRE-Measurements = folder containing all raw data files for the resting vagally-mediated Heart Rate Variability measurement at the PRE-Measurements (1.2.2) POST-Measurements = folder containing all raw data files for the resting vagally-mediated Heart Rate Variability measurement at the PRE-Measurements File naming: (1) EEG-Data: Data labels: - ID = study participant ID (= variable 'pat-ID') - Brain-IT-Pilot-Feasibility-RCT = project name - EEG = EEG data - PRE/POST = definition of Pre/Post measurement - status = definition of data status (i.e. 'rawdata' (= raw data), 'preprocessed_eyeclosed' (= all preproccessing steps completed and epoched for sections with eyesclosed; according to study protocol) - .datatype = definition of datatype (i.e. 'fdt', 'set') Structure: ID_Brain-IT-Pilot-Feasibility-RCT_EEG_PRE/POST_status.datatype Example: P-11000001_Brain-IT-Pilot-Feasibility-RCT_EEG_PRE_rawdata.CSV (2) HRV Data: Data labels: - ID = study participant ID (= variable 'pat-ID') - Brain-IT-Pilot-Feasibility-RCT = project name - HRV = HRV data - PRE/POST = definition of Pre/Post measurement - .datatype = definition of datatype (i.e. CSV) Structure: ID_Brain-IT-Pilot-Feasibility-RCT_HRV_PRE/POST.datatype Example: P-11000001_Brain-IT-Pilot-Feasibility-RCT_HRV_PRE.CSV