Trial Outcomes & Findings for CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults (NCT NCT04534686)

NCT ID: NCT04534686

Last Updated: 2025-08-28

Results Overview

This test is conducted to assess leg strength and endurance. Participants are asked to stand in front of a sturdy chair and monitored by the remote research personnel during the test. The participants are instructed to sit in the middle of the chair. Place their hands on the opposite shoulder crossed, at the wrists. Keep their feet flat on the floor and back straight with arms against their chest. Then the following instruction "On "Go," rise to a full standing position, then sit back down again. 6. Repeat this for 30 seconds" is provided to conduct the test and assessed by the research personnel remotely. This test is easy to perform and requires a sturdy chair (available at every home) and will be performed in front of the camera during the zoom meeting for the research personnel to monitor and collect the required data. Higher values indicate better performance

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
• Results posted on: 2025-08-28

Participant Flow

We initially recruited the participants by posting flyers (approved by the Institutional Review Board) at Geriatric and internal medicine by contacting collaborators, giving presentations to potential participants at various exercise centers and senior homes. We will also use social media, such as Facebook, Twitter, etc. to post flyer for recruitment

Participant milestones

Measure	CogXergaming CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
Baseline Measurement STARTED	22	23
Baseline Measurement Mid-intervention	18	18
Baseline Measurement COMPLETED	15	16
Baseline Measurement NOT COMPLETED	7	7
Intervention STARTED	15	16
Intervention COMPLETED	13	14
Intervention NOT COMPLETED	2	2

Reasons for withdrawal

Measure	CogXergaming CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
Baseline Measurement Lost to Follow-up	4	6
Baseline Measurement Withdrawal by Subject	3	1
Intervention Withdrawal by Subject	2	2

Baseline Characteristics

CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults

Baseline characteristics by cohort

Measure	CogXergaming n=22 Participants CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training n=23 Participants Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.	Total n=45 Participants Total of all reporting groups
Age, Continuous	72.15 years STANDARD_DEVIATION 6.03 • n=5 Participants	71.83 years STANDARD_DEVIATION 5.98 • n=7 Participants	72.13 years STANDARD_DEVIATION 5.84 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Montreal Cognitive Assessment	27.34 units on a scale STANDARD_DEVIATION 5.01 • n=5 Participants	27.60 units on a scale STANDARD_DEVIATION 4.82 • n=7 Participants	27.36 units on a scale STANDARD_DEVIATION 4.82 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: 13 participants in the Coxergaming and 14 in the Matter of Balance group completed the study and data was analyzed for these participants.

This test is conducted to assess leg strength and endurance. Participants are asked to stand in front of a sturdy chair and monitored by the remote research personnel during the test. The participants are instructed to sit in the middle of the chair. Place their hands on the opposite shoulder crossed, at the wrists. Keep their feet flat on the floor and back straight with arms against their chest. Then the following instruction "On "Go," rise to a full standing position, then sit back down again. 6. Repeat this for 30 seconds" is provided to conduct the test and assessed by the research personnel remotely. This test is easy to perform and requires a sturdy chair (available at every home) and will be performed in front of the camera during the zoom meeting for the research personnel to monitor and collect the required data. Higher values indicate better performance

Outcome measures

Measure	CogXergaming n=13 Participants CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training n=14 Participants Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
Change in 30-second Chair Stand Performance Baseline	10.28 number of repetitions Standard Deviation 1.63	12.11 number of repetitions Standard Deviation 1.81
Change in 30-second Chair Stand Performance Immediate Post-training	12.36 number of repetitions Standard Deviation 1.62	12.30 number of repetitions Standard Deviation 1.53

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: 13 participants in the Coxergaming and 14 in the Matter of Balance group completed the study and data was analyzed for these participants.

Walking performance will be assessed using the Tinetti Performance Oriented Mobility Assessment. This test contains components of gait and balance assessment and is scored on a scale, typically from 0 to 2, with higher scores indicating better performance. The total score combines the scores from both sections, with a minimum score of 0 and a maximum score of 28. This test will be evaluated remotely over zoom. A safe area visible to the research personnel remotely will be chosen and only then the test will be administered. During this test, the research personnel will ensure that he/she is constantly visible in the screen and measure the time taken to complete the test. Higher scores on the test indicate better performance.

Outcome measures

Measure	CogXergaming n=13 Participants CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training n=14 Participants Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
Change in Walking Performance Baseline	25.93 scores on a scale of 28 Standard Deviation 2.12	26.95 scores on a scale of 28 Standard Deviation 1.16
Change in Walking Performance Immediate Post-training	26.92 scores on a scale of 28 Standard Deviation 0.75	26.93 scores on a scale of 28 Standard Deviation 1.22

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Cardiovascular fitness will be assessed using the 2-min step test, which will be conducted remotely via zoom. The participant is asked to stand up straight next to the wall while a mark is placed on the wall at the level corresponding to midway between the kneecap and top of the hip bone. The subject then marches in place for two minutes, lifting the knees to the height of the mark on the wall. Resting is allowed and holding onto the wall or a stable chair is allowed. Stop after two minutes of stepping. The remote research personnel records the total number of times the right knee reaches the tape level in two minutes. Higher scores on the test indicate better performance

Outcome measures

Measure	CogXergaming n=13 Participants CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training n=14 Participants Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
Change in Cardiovascular Fitness Baseline	75.06 number of repetitions Standard Deviation 16.51	78.61 number of repetitions Standard Deviation 10.97
Change in Cardiovascular Fitness Immediate Post-training	85.45 number of repetitions Standard Deviation 11.52	82.71 number of repetitions Standard Deviation 10.27

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: 13 participants in the Coxergaming and 14 in the Matter of Balance group completed the study and data was analyzed for these participants.

Physical activity will be assessed remotely via zoom using the scoring of the Physical Activity Scale for the Elderly (PASE) involves assigning weights to different types of physical activities based on their intensity and frequency. Respondents report their weekly frequency and duration of various activities, which are then multiplied by predetermined weights. The total PASE score is the sum of these weighted values, providing a single numeric value representing the individual's overall physical activity level. Higher scores indicate higher levels of physical activity. The minimum score for PASE is 0 and maximum score is 793.

Outcome measures

Measure	CogXergaming n=13 Participants CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training n=14 Participants Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
Change in Physical Activity Baseline	72.68 scores on a scale of 793 Standard Deviation 38.10	77.11 scores on a scale of 793 Standard Deviation 40.8
Change in Physical Activity Immediate post-training	110.03 scores on a scale of 793 Standard Deviation 23.80	92.49 scores on a scale of 793 Standard Deviation 29.4

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

It is the average speed of center of gravity movement during intentional movement measured in degrees per second under single and dual-task conditions. Higher values indicate better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

It is the magnitude of a self-initiated movement (i.e., how far he/she wills to reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

It is the quality of a self-initiated movement (i.e., amount of movement actually exhibited towards the target to the amount of extraneous movement away from the target) measured in percentage under single and dual-task conditions. Higher values indicate better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

It is the actual magnitude of a self-initiated movement (i.e., how far did he/she actually reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Reactive balance control will be examined via the stance perturbation test under single and dual-task conditions (simultaneous performance of Letter number sequencing task or auditory stroop task). Postural stability can be defined as simultaneous control of center of mass (COM) position and velocity during slip-like or trip like perturbation relative to the rear edge of base of support (rear heel). The position is normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Larger values indicate greater stability.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

This is an oral trail making test which includes listing alternate letter and number from the cue given in sequence. This test will be performed under single and dual-task conditions.

Accuracy (number of correct responses out of the total responses) of letter number sequencing will be calculated. Higher accuracy indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

The total time taken to complete the 4 meters will be noted. Speed will then be determined by using the formula distance (4 meters) covered by time taken to complete the test. Higher speed indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Spatial and temporal gait parameters like step length, cadence and stride length will be determined during single and dual-task walking performance via the GaitRite mat. Higher values for step length and stride length, and lower cadence indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

This test involves responding to the pitch (high or low) of the words "High" or "Low". This test will be performed under single and dual-task conditions.

Accuracy (number of correct responses out of the total responses) of Auditory stroop will be calculated. Higher accuracy indicates better performance. Higher values indicate better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Dual-task motor and cognitive cost will be calculated using the formula- [(Dual-task performance- Single Task performance)/Single task performance]. This will be calculated for dual-task performance during intentional postural sway, reactive balance control and gait conditions. Lower cost indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Interference in the reaction time via visual stroop task where the individual is expected to respond to the color in which the word is printed and not read the word. Performance will be identified via time taken to complete the test. Lower time indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Language fluency via verbal and category task will be administered. Performance will be identified via the total number of appropriate words responded on each of the task. Higher values indicate better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

The individual is asked to hit a key on the number keypad when a cue appears on the screen. Performance will be identified with time taken to hit the key after the individual sees the cue in seconds. Lower time indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Paired associated learning via grid task will be administered. Accuracy (number of correct responses out of the total responses) will be represented in percentage. Higher value indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Spatial working memory via unveil the star task will be administered. Performance will be identified via the total time (in seconds) to complete the task. Lower time indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: 13 participants in the Coxergaming and 14 in the Matter of Balance group completed the study and data was analyzed for these participants.

List Sorting Memory test to evaluate working memory. This test requires the participant to recall and sequentially list the visually and orally presented stimuli. The accuracy of the participant's response is computer generated. Higher value indicates better performance. The minimum score is 0% and maximum score is 100%

Outcome measures

Measure	CogXergaming n=13 Participants CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. CogXergaming: The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.	Matter of Balance Training n=14 Participants Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). Matter of Balance Training: The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
Change in Working Memory Baseline	16.11 percentage Standard Deviation 3.3	16.22 percentage Standard Deviation 3.3
Change in Working Memory Immediate post-training	16.85 percentage Standard Deviation 3.93	16.11 percentage Standard Deviation 2.93

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Picture sequence memory test will assess episodic memory of the individual. The number of adjacent pairs of pictures placed correctly will score a point. The scores are computer generated. Higher value indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Flanker inhibitory control and attention test is used to evaluate the participant's ability to inhibit the attention to the stimulus flanking it and focus on a particular stimulus. Accuracy of the responses are recorded and the scores are computer generated. Higher value indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Dimensional Change card sort assesses cognitive flexibility and attention. Participants are asked to match a series of bivalent pictures either by colors or shapes accordingly. Responses are computer recorded and accuracy scores are computer generated. Higher value indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Pattern comparison processing speed test is used to evaluate the processing speed. The participants are expected to respond whether the two pictures side-by side are same or not the same. Accuracy will be recorded by the computer and scores are computer generated. Higher value indicates better performance.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Image acquisition will be performed in a 3T and 1.5T Magnetic resonance scanner (MR 750, GE healthcare, Milwaukee). Fractional anisotropy (FA) is a scalar value ranging from 0-1 and change from pre- to post-training will compared to determine the structural and functional connectivity. Increase in FA values post-training will indicate positive results of training.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Assess static and dynamic balance. This scale consists of the participant transferring from one chair to another, reaching forward, stepping up and down from a stepping stool, standing with eyes closed and open, one leg standing. It is a 14-item scale with each item score ranging from 0-4. Performance on the scale will be calculated on a total of 56. Less than 45 will indicate greater risk of falling.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Questionnaires such as Physical Activity Scale for elderly and activity specific balance confidence scale will be self-reported by the participant. Activity specific balance confidence scale consists of 16 items, and each item score ranges from 0-100. The total score with 0 confidence indicates no confidence and 100 with complete confidence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)

Population: Due to the emergence of the COVID-19 pandemic, this study was conducted primarily on Zoom, preventing the collection of data for this outcome measure, as the assessment is typically conducted in person.

Average number of steps taken a day by the individual prior to and after training.

Outcome measures

Outcome data not reported

Adverse Events

CogXergaming

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Matter of Balance Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tanvi Bhatt

University of Illinois at Chicago

Phone: 3123554443

Email: tbhatt6@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place