The Effects of Exergaming on Executive and Physical Functions in Older Adults With Dementia: Randomized Controlled Trial

Background Despite increasing interest in the effects of exergaming on cognitive function, little is known about its effects on older adults with dementia. Objective The purpose of this is to investigate the effects of exergaming on executive and physical functions in older adults with dementia compared to regular aerobic exercise. Methods In total, 24 older adults with moderate dementia participated in the study. Participants were randomized into either the exergame group (EXG, n=13, 54%) or the aerobic exercise group (AEG, n=11, 46%). For 12 weeks, EXG engaged in a running-based exergame and AEG performed a cycling exercise. At baseline and postintervention, participants underwent the Ericksen flanker test (accuracy % and response time [RT]) while recording event-related potentials (ERPs) that included the N2 and P3b potentials. Participants also underwent the senior fitness test (SFT) and the body composition test pre- and postintervention. Repeated-measures ANOVA was performed to assess the effects of time (pre- vs postintervention), group (EXG vs AEG), and group×time interactions. Results Compared to AEG, EXG demonstrated greater improvements in the SFT (F1.22=7.434, P=.01), reduction in body fat (F1.22=6.476, P=.02), and increase in skeletal mass (F1.22=4.525, P=.05), fat-free mass (F1.22=6.103, P=.02), and muscle mass (F1.22=6.636, P=.02). Although there was a significantly shorter RT in EXG postintervention (congruent P=.03, 95% CI 13.581-260.419, incongruent P=.04, 95% CI 14.621-408.917), no changes occurred in AEG. EXG also yielded a shorter N2 latency for central (Cz) cortices during both congruent conditions compared to AEG (F1.22=4.281, P=.05). Lastly, EXG presented a significantly increased P3b amplitude compared to AEG during the Ericksen flanker test (congruent: frontal [Fz] F1.22=6.546, P=.02; Cz F1.22=5.963, P=.23; parietal [Pz] F1.22=4.302, P=.05; incongruent: Fz F1.22=8.302, P=.01; Cz F1.22=15.199, P=.001; Pz F1.22=13.774, P=.001). Conclusions Our results suggest that exergaming may be associated with greater improvements in brain neuronal activity and enhanced executive function task performance than regular aerobic exercise. Exergaming characterized by both aerobic exercise and cognitive stimulation can be used as an effective intervention to improve cognitive and physical functions in older adults with dementia. Trial Registration Clinical Research Information Service KCT0008238; https://cris.nih.go.kr/cris/search/detailSearch.do/24170

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. * yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed 其他: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.  T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u  s  . subitem not at all important a  t  u  r  e  s  /  f  u  n  c  t  i  o  n  a  l  i  t  i  e  s  /  c  o  m  p  o  n  e  n  t  s  o  f  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  a  n  d  c  o  m  p  a  r  a  t  o  r  i  n  t  h  e  M  E  T  H  O  D  S  s  e  c  t  i  o  n  o  f  t  h  e  A  B  S  T  R  A  C  T Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Background: Despite increasing interest in the effects of exergame on cognitive function, little is known about its effects on older adults with dementia. Objective: The purpose of the present study was to investigate the effects of exergame in comparison to regular aerobic exercise on executive function and physical function in older adults with dementia. Methods: Twenty-four older adults with moderate dementia (80 ± 4.7 years old) participated in the study. Participants were randomized into either exergame group (EXG, n=13) or aerobic exercise group (AEG, n=11). The interventions lasted for 12 weeks and the Ericksen Flanker task was administered to assess executive function. The Flanker task performance accuracy (%) and response time (RT) and event-related potential (N2 and P3b) during the task were measured. Physical function was assessed using senior fitness test (SFT) before and after the intervention.

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subitem not at all important Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Methods: Twenty-four older adults with moderate dementia (80 ± 4.7 years old) participated in the study. Participants were randomized into either exergame group (EXG, n=13) or aerobic exercise group (AEG, n=11). The interventions lasted for 12 weeks and the Ericksen Flanker task was administered to assess executive function. The Flanker task performance accuracy (%) and response time (RT) and event-related potential (N2 and P3b) during the task were measured. Physical function was assessed using senior fitness test (SFT) before and after the intervention.  I  N  T  R  O  D  U  C  T  I  O  N   2  a  )  I  n  I  N  T  R  O  D  U  C  T  I  O  N  :  S  c  i  e  n  t  i  f  i  c  b  a  c  k  g  r  o  u  n  d  a  n  d  e  x  p  l  a  n  a  t  i  o  n  o  f  r  a  t  i  o  n  a  l  e subitem not at all important Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Conclusions: Our results suggest that exergame may be associated with greater improvements in brain neuronal activity and enhanced executive function task performance than regular aerobic exercise. Exergame characterized by both aerobic exercise and cognitive stimulation can be employed as an effective intervention to improve cognitive and physical function in older adults with dementia. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Executive function is a family of at least three different functions that include the maintenance and execution of target tasks by suppressing interference factors caused by unnecessary information in the information processing process [1]. Execution function is not a single structure but can be divided into (1) core: consists of inhibition, renewal / working memory, conversion; (2) higher-level: consists of plan / solve problems, and depends heavily on the frontal lobes [2, 3]. Executive dysfunction often represents agerelated cognitive decline and dementia, which are also associated with declining ability to independently maintain activities of daily living [4][5][6]. Indeed, dementia-related deficits in executive function cause fatal impairment in activities in daily living in older adults [7,8]. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Executive function is a family of at least three different functions that include the maintenance and execution of target tasks by suppressing interference factors caused by unnecessary information in the information processing process [1]. Execution function is not a single structure but can be divided into (1) core: consists of inhibition, renewal / working memory, conversion; (2) higher-level: consists of plan / solve problems, and depends heavily on the frontal lobes [2, 3]. Executive dysfunction often represents agerelated cognitive decline and dementia, which are also associated with declining ability to independently maintain activities of daily living [4][5][6]. Indeed, dementia-related deficits in executive function cause fatal impairment in activities in daily living in older adults [7,8]. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The present study shows that exergame is an effective approach to improve the executive and physical functions in older adults with dementia. Therefore, regular participation in exergame can be suggested as an effective alternative to aerobic exercise for treatment and early prevention of older adults with dementia. Future studies need to replicate the present results using a non-exercise control group and large number of participants. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All participants had 2 weeks of familiarization period before starting 12 weeks of both exergame and aerobic exercise training. The frequency of both EXG and AEG was 3 days/week. The intensity of both groups was 60-70% of heart rate reserved (HRR) and was gradually increased (i.e., 30 minutes for 1-2 weeks, 35 minutes for 3 weeks, 40 minutes for 4-5 weeks, 45 minutes for 6-7 weeks, 50 minutes for 8-12 weeks). The reaction time (RT) and electrophysiological signal from the frontal (Fz), central (Cz), and parietal (Pz) cortex were collected during a Eriksen flanker task twice, pre-and post-exercise training. Physical function was assessed using senior fitness test (SFT) before and after the intervention.
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All participants had 2 weeks of familiarization period before starting 12 weeks of both exergame and aerobic exercise training. The frequency of both EXG and AEG was 3 days/week. The intensity of both groups was 60-70% of heart rate reserved (HRR) and was gradually increased (i.e., 30 minutes for 1-2 weeks, 35 minutes for 3 weeks, 40 minutes for 4-5 weeks, 45 minutes for 6-7 weeks, 50 minutes for 8-12 weeks). The reaction time (RT) and electrophysiological signal from the frontal (Fz), central (Cz), and parietal (Pz) cortex were collected during a Eriksen flanker task twice, pre-and post-exercise training. Physical function was assessed using senior fitness test (SFT) before and after the intervention.
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All participants had 2 weeks of familiarization period before starting 12 weeks of both exergame and aerobic exercise training. The frequency of both EXG and AEG was 3 days/week. The intensity of both groups was 60-70% of heart rate reserved (HRR) and was gradually increased (i.e., 30 minutes for 1-2 weeks, 35 minutes for 3 weeks, 40 minutes for 4-5 weeks, 45 minutes for 6-7 weeks, 50 minutes for 8-12 weeks). The reaction time (RT) and electrophysiological signal from the frontal (Fz), central (Cz), and parietal (Pz) cortex were collected during a Eriksen flanker task twice, pre-and post-exercise training. Physical function was assessed using senior fitness test (SFT) before and after the intervention.
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All participants completed a written informed consent form approved by the Institutional Review Board of Pusan National University (PNU IRB/2018_59_HR).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The reaction time (RT) and electrophysiological signal from the frontal (Fz), central (Cz), and parietal (Pz) cortex were collected during a Eriksen flanker task twice, pre-and postexercise training. Physical function was assessed using senior fitness test (SFT) before and after the intervention.
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

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subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The reaction time (RT) and electrophysiological signal from the frontal (Fz), central (Cz), and parietal (Pz) cortex were collected during a Eriksen flanker task twice, pre-and postexercise training. Physical function was assessed using senior fitness test (SFT) before and after the intervention. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.  Fig. 2A). ExerHeart® is an intelligent exercise management service developed by medical experts and exercise experts. We used a game called "Alchemist's Treasure", which is a running game based on the Talesrunner IP and co-developed with ExerHeart® ( Fig. 2B). During playing "Alchemist's Treasure", players run with the avatar, avoiding obstacles, and win items using the front, back, left, and right while running or jumping at speed on the mat.
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).  Fig. 2A). ExerHeart® is an intelligent exercise management service developed by medical experts and exercise experts. We used a game called "Alchemist's Treasure", which is a running game based on the Talesrunner IP and co-developed with ExerHeart® (Fig. 2B). During playing "Alchemist's Treasure", players run with the avatar, avoiding obstacles, and win items using the front, back, left, and right while running or jumping at speed on the mat.

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Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All participants had 2 weeks of familiarization period before starting 12 weeks of both exergame and aerobic exercise training. The frequency of both EXG and AEG was 3 days/week. The intensity of both groups was 60-70% of heart rate reserved (HRR) and was gradually increased (i.e., 30 minutes for 1-2 weeks, 35 minutes for 3 weeks, 40 minutes for 4-5 weeks, 45 minutes for 6-7 weeks, 50 minutes for 8-12 weeks). All participants' heart rates (HR) were measured during exercise using HR monitors (polar RS400sd, Madison Height, Michigan, USA). HRR was calculated by using the Karvonen formula [37]. AEG performed exercise using commercial recumbent cycle 704 (EGOJIN, China). The initial bicycle resistance was 0 Kp and the exercise intensity was increased by 1 Kp every 5 minutes. Different resistance between male and female was used during the exercise to account for the sex-related difference in the cardiorespiratory fitness and lower-body strength (e.g., Male: 1 to 3 weeks up to 3 Kp, 4 to 12 weeks up to 4 Kp; Female: 1 to 3 weeks up to 2 Kp, 4 to 12 weeks up to 3 Kp). EXG performed exercise using ExerHeart® devices (D&J Humancare, Busan, South Korea) that comes with a running/jumping mat [950(W) × 1300(D) × 1700(H)] ( Fig. 2A). ExerHeart® is an intelligent exercise management service developed by medical experts and exercise experts. We used a game called "Alchemist's Treasure", which is a running game based on the Talesrunner IP and co-developed with ExerHeart® (Fig. 2B). During playing "Alchemist's Treasure", players run with the avatar, avoiding obstacles, and win items using the front, back, left, and right while running or jumping at speed on the mat. Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator". Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We used the Shapiro-Wilk test to assess whether the data were normally distributed. The behavioral (i.e., accuracy rate and reaction time) and event-related potential (i.e., N2, P3b amplitude) data were analyzed using repeated-measures ANOVA to determine group (EXG vs AEG) × time (before vs after intervention) interaction. We also used the paired t-test (or Wilcoxon signed rank test) to examine the changes of each dependent variable after the intervention within each group. Bonferroni post-hoc analyzes were performed when there was a significant difference. Partial eta squared (η2p) was used to assess the effect size. The statistical significance was set at alpha = 0.05. All statistical tests were conducted using SPSS (v. 24.0). We used the Shapiro-Wilk test to assess whether the data were normally distributed. The behavioral (i.e., accuracy rate and reaction time) and event-related potential (i.e., N2, P3b amplitude) data were analyzed using repeated-measures ANOVA to determine group (EXG vs AEG) × time (before vs after intervention) interaction. We also used the paired t-test (or Wilcoxon signed rank test) to examine the changes of each dependent variable after the intervention within each group. Bonferroni post-hoc analyzes were performed when there was a significant difference. Partial eta squared (η2p) was used to assess the effect size. The statistical significance was set at alpha = 0.05. All statistical tests were conducted using SPSS (v. 24.0).  (Fig. 3B). Table 2 shows congruent and incongruent N2 amplitude and latency and Figure 4 shows the waveforms of congruent and incongruent N2 amplitude before and after intervention. There was no significant group × time interaction in congruent and incongruent N2 amplitude on Fz, Cz, and Pz. However, EXG significantly increased congruent N2 amplitude on Fz, Cz, and Pz after intervention, whereas AEG showed no significant changes. For incongruent N2 amplitude on Fz, Cz, and Pz, there were no significant changes in both EXG and AEG. On the other hand, there was a significant group × time interaction in congruent N2 latency on Cz, but not on Fz and Pz. EXG significantly shortened congruent N2 latency on Cz after intervention, but AEG did not. Both EXG and AEG did not significantly change congruent N2 latency on Fz and Pz after intervention. For incongruent N2 latency on Fz, Cz, and Pz, there was no significant group × time interaction. Also, both EXG and AEG did not significantly change incongruent N2 latency on Fz, Cz, and Pz after intervention. As shown in Table 2, there were significant group × time interactions in both congruent and incongruent P3b amplitude on Fz, Cz, and Pz. EXG significantly increased congruent P3b amplitude on Fz and Cz after intervention, but not on Pz. However, AEG did not significantly change congruent P3b amplitude on Fz, Cz, and Pz after intervention. Similarly, EXG significantly increased incongruent P3b amplitude on Fz, Cz, and Pz after intervention, but AEG did not. On the other hand, there was no significant group × time interaction in both congruent and incongruent P3b latency on Fz, Cz, and Pz. In addition, both EXG and AEG did not significantly change incongruent P3b latency on Fz, Cz, and Pz after intervention. The waveforms of congruent and incongruent P3b amplitude Fz, Cz, and Pz for EXG and AEG before and after exercise are shown in Figure 4. The results of SFT in EXG and AEG after intervention were shown in Figure 5. There was a significant group × time interaction in cardiopulmonary endurance (p=0.012, η2p=0.253  T  E  :  P  r  e  f  e  r  a  b  l  y  ,  t  h  i  s  i  s  s  h  o  w  n  i  n  a  C  O  N  S  O  R  T  f  l  o  w  d  i  a  g  r  a  m  ) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No losses and exclusions after randomisation Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study the analysis was by original assigned groups Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time)   (Fig. 3B). Table 2 shows congruent and incongruent N2 amplitude and latency and Figure 4 shows the waveforms of congruent and incongruent N2 amplitude before and after intervention. There was no significant group × time interaction in congruent and incongruent N2 amplitude on Fz, Cz, and Pz. However, EXG significantly increased congruent N2 amplitude on Fz, Cz, and Pz after intervention, whereas AEG showed no significant changes. For incongruent N2 amplitude on Fz, Cz, and Pz, there were no significant changes in both EXG and AEG. On the other hand, there was a significant group × time interaction in congruent N2 latency on Cz, but not on Fz and Pz. EXG significantly shortened congruent N2 latency on Cz after intervention, but AEG did not. Both EXG and AEG did not significantly change congruent N2 latency on Fz and Pz after intervention. For incongruent N2 latency on Fz, Cz, and Pz, there was no significant group × time interaction. Also, both EXG and AEG did not significantly change incongruent N2 latency on Fz, Cz, and Pz after intervention. As shown in Table 2, there were significant group × time interactions in both congruent and incongruent P3b amplitude on Fz, Cz, and Pz. EXG significantly increased congruent P3b amplitude on Fz and Cz after intervention, but not on Pz. However, AEG did not significantly change congruent P3b amplitude on Fz, Cz, and Pz after intervention. Similarly, EXG significantly increased incongruent P3b amplitude on Fz, Cz, and Pz after intervention, but AEG did not. On the other hand, there was no significant group × time interaction in both congruent and incongruent P3b latency on Fz, Cz, and Pz. In addition, both EXG and AEG did not significantly change incongruent P3b latency on Fz, Cz, and Pz after intervention. The waveforms of congruent and incongruent P3b amplitude Fz, Cz, and Pz for EXG and AEG before and after exercise are shown in Figure 4. The results of SFT in EXG and AEG after intervention were shown in Figure 5. There was a significant group × time interaction in cardiopulmonary endurance (p=0.012, η2p=0.253 The present study investigated the effects of exergame and aerobic exercise on executive function and physical function in older adults with dementia. We found a significant shorter flanker task RT in response to exergame training. Moreover, exergame generally yielded larger increases in neural activities that are related to attention and working memory, and greater enhancement in lower body muscle strength and cardiorespiratory endurance compared to aerobic exercise. In terms of behavioral performance, shorter flanker task RT following exergame training in both congruent and incongruent signals in the present study indicates the greater facilitation of executive function. In our previous finding, both exergaming and treadmill exercise resulted in significantly shorter Stroop task RT in patients with metabolic syndrome through improvements in basic information processing and executive function suppression control [39]. Another study noted that combining physical and cognitive stimulation in 8 weeks of multimodal exercise substantially improved information processing speed in older adults [40]. Collectively, participating in aerobic exercise training improves information processing speed in older adults, regardless of the exercise intensity and type. Consistent with the results of these previous studies, the results of the present study showed that exergame training resulted in a significant improvement in information processing speed, suggesting that auditory, visual and motor sensory stimulation during exergaming could accelerate information processing speed in elderly people with dementia. Although there was no significant interaction between the group and the intervention in the present study, there was no significant change in flanker task RT by aerobic exercise group, so we cannot rule out the possibility that exergaming has a more beneficial effect on information processing speed than general aerobic exercise. In the present study, exergame training significantly increased the congruent N2 amplitude in the Fz and Cz cortices, and reduced latency in the Cz cortex. Distinguishing stimulus and cognitive processes are closely related to attention during the tasks [41]. Hwang and colleagues found that reduced N2 activation in the central lobe and occipital cortex after acute aerobic exercise [42]. Similarly, decreased N2 amplitude and longer N2 latency were observed during exercise [43]. We previously reported increased N2 amplitude in response to exergame training, suggesting that exergame effectively increases selective attention by regulating the activities of the central and occipital cortex [39]. Performing exercise in a virtual environment also increased N2 amplitude and reduced latency [31]. These changes in brain activity reflect exercise with extra environmental stimulation promoted decision making (frontal and central areas) and visual perception (occipital areas). In this context, using cognition-stimulating games may facilitate the ability to clearly distinguish stimuli by activating the cerebral cortex with visual and auditory stimuli, thereby promoting cognitive processes. Therefore, our findings suggest that exergame improves attention by effectively promoting neuronal activity in older individuals with dementia. Furthermore, considering that in the present study, the N2 latency after exergame was shorter than that of aerobic exercise, and the congruent N2 amplitude and latency were not changed with the aerobic exercise, it is still possible that exergame may have a greater effect on neural activity related to executive function and attention compared to than a simple form of aerobic exercise. We also found a greater increase in congruent and incongruent P3b amplitude with exergame than aerobic exercise in the present study. This suggests that exergame may have a greater effect on working memory than general aerobic exercise. Tsai and colleagues reported that performing resistance training for 12 months was associated with maintaining subitem not at all important 1 2 3 4 5 essential epo ted t at pe o g es sta ce t a g o o t s as assoc ated t a ta g the capacities for allocating attention as measured by P3b amplitude in healthy older males [44]. Our previous investigation also found that aerobic exercise and resistance exercise have positive effects on neuronal activation, especially on the P3b amplitude in young adults [45]. Additionally, exergame improved categorization of the incoming information and updating the context of working memory as measured by P300 amplitude in patients with metabolic syndrome [39]. Taken together, both exercise and exergame induce brain activity through visual perceptual stimuli and activate nerve cells in the brain to promote information processing related to stimuli judgment and decision making. Extending on these results, the results of this study clearly indicate that exergame can be a more effective intervention in improving the classification of input information and working memory in the elderly with dementia compared to general aerobic exercise. A recent meta-analysis showed that interventions combining both physical training and cognitive training improved cognitive function than physical training alone [46], and our previous study supports the results of the meta-analysis [39]. In turn, better executive function is thought to be supported by healthy lifestyle interventions, including physical activity [47]. Thus, the exergame intervention used in the present study would have increased the brain's ability to rapidly recognize consistent and inconsistent stimuli and simultaneously make judgements, faster than normal aerobic exercise. It is also important to note that exergame showed greater improvements in lower body muscle strength and cardiorespiratory endurance compared to aerobic exercise. During the "Alchemist Treasure" game in the ExerHeart@ device used in this study, participants had to continuously walk or adjust their body position. These constant body movements throughout the game may also have resulted in improvements in their cardiorespiratory endurance. Our results are in agreement with a previous study showing that exergame program effectively improved cardiopulmonary endurance and leg muscle strength in healthy middle-aged and older adults [48]. In addition, lower body strength is closely related to cardiopulmonary endurance [49], and aerobic exercise improves repetitive muscle contraction and cardiopulmonary endurance and enhances everyday abilities such as climbing stairs or sitting and standing up from a chair [50]. Therefore, exergame may be an effective exercise in improving the lower body muscle strength and cardiorespiratory endurance of older adults. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The present study has some limitations. First, our study does not have a non-exercise control group, warranting some caution in the interpretation of the results. Nevertheless, pre-posttest designs are commonly used to assess the effectiveness of intervention over time, and our results are consistent with other exercise intervention studies that have shown significant interventional effects in older adults with dementia. Thus, it is not likely that our results simply reflect passage of time or other nonspecific intervention effects. Second, we had a relatively small number of participants (n=24) and homogeneous characteristic (e.g., all Asians). As a result, the statistical power may be lower in this study, but at least to compensate for this problem, the effect sizes were calculated as references. Finally, since our study is limited to using only a single exergame, it is necessary to verify the effectiveness of other games. Therefore, these limitations may need to be supplemented in future studies.  T  :  E  x  t  e  r  n  a  l  v  a  l  i  d  i  t  y  o  f  t  h  e  t  r  i  a  l  f  i  n  d  i  n  g  s  a  c  c  o  r  d  i  n  g  t  o  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  ,  c  o  m  p  a  r  a  t  o  r  s  ,  p  a  t  i  e  n  t  s  ,  a  n  d  c  a  r  e  p  r  o  v  i  d  e  r  s  o  r  c  e  n  t  e  r  s  i  n  v  o  l  v  e  d  i  n  t  h  e  t  r  i  a  Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The full protocol is not publicly available but can be requested through the corresponding author.