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

NCT04534686 | Completed Results

• 1 other identifier: 2020-0280
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the age associated sarcopenia and reduced cardiovascular fitness, frail older adults experience significant decrease in physical function which comprises of mobility, endurance, muscle strength and balance control. The impaired physical function results in poor quality of life and reduced community participation, leading to increased frailty and long-term disability. Further, compared to cognitively intact frail older adults, cognitively impaired frail older adults experience greater deterioration of such physical function, specifically during dual-task performances (i.e., simultaneous performance of cognitive and motor task). This deterioration occurs due to increased cognitive-motor interference as a result of dual-tasking and is known to increase exhaustion among frail older adults. Previous studies have used multicomponent training and have shown to improve physical function and maintain cardiovascular functioning. However, the capacity of such interventions to improve cognitive function along with physical function is not known or unclear. Further, the concurrent comorbidities that occur along with psychosocial issues such as depression present as barriers and lead to reduced compliance to therapy leaving only a few of them to benefit from it. Alternate forms of therapy such as exergaming with explicit cognitive training has shown promising effects in improving motor and motor function in disabled populations. These studies use a cost-effective, off the shelf device such as Nintendo Wii or Microsoft Kinect to deliver the training which is easily available and clinically translatable. Further, such training has demonstrated increase in brain connectivity enhancing cognitive functions associated with balance control. However, there is limited literature examining the effect of exergaming in older frail population and the efficacy of such training is unknown. Therefore, this study proposes a randomized controlled trial to examine the feasibility of CogXergaming program with an aim to improve locomotor-balance control, cognition, muscular system and cardiovascular fitness.

Conditions

Frail Older Adults

Keywords

CogXergaming; Dual-task training; Cognitive-motor-balance training

Outcome Measures

Primary Outcomes (25)

• Change in 30-second Chair Stand Performance

  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

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

• Change in Walking Performance

  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.

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

• Change in Cardiovascular Fitness

  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

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

• Change in Physical Activity

  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.

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

• Change in Movement Velocity

  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.

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

• Change in End Point Excursion

  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.

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

• Change in Directional Control

  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.

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

• Change in Maximum Excursion

  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.

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

• Change in Postural Stability During Reactive Balance Control (Single and Dual-task)

  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.

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

• Change of Accuracy in Letter Number Sequencing

  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.

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

• Change in 4 Meter Walk Test

  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.

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

• Change in Spatial and Temporal Gait Parameters

  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.

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

• Change in Accuracy of Auditory Stroop

  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.

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

• Change in Dual-task Cost

  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.

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

• Change in Interference in the Reaction Time

  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.

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

• Change in Language Fluency

  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.

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

• Change in Reaction Time

  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.

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

• Change in Paired Associated Learning

  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.

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

• Change in Spatial Working Memory

  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.

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

• Change in Working Memory

  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%

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

• Change in Episodic Memory

  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.

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

• Change in Accuracy of Flanker Inhibitory Control and Attention Test

  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.

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

• Change in Cognitive Flexibility and Attention

  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.

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

• Change in Processing Speed

  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.

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

• Changes in Fractional Anisotropy

  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.

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

Secondary Outcomes (3)

• Berg Balance Scale

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

• Change in Physical Activity Level (Questionnaires)

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

• Change in Physical Activity Level

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

Study Arms (2)

CogXergaming

EXPERIMENTAL

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.

Behavioral: CogXergaming

Matter of Balance Training

EXPERIMENTAL

Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day).

Behavioral: Matter of Balance Training

Interventions

CogXergaming BEHAVIORAL

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.

Also known as: Cognitive training

CogXergaming

Matter of Balance Training BEHAVIORAL

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.

Also known as: Conventional training

Matter of Balance Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults aged 60 years or above
• Walking speed \<0.8m/s
• Self-reported Physical activity \<3 hours/week
• Hand grip strength \<30 kgs for men \& \<20 kgs for women
• Not on any sedative drugs
• Can understand \& communicate in English
• Ability to walk more than 30 feet with or without an assistive device

You may not qualify if:

• Participants will not proceed with the study if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and/or 3) oxygen saturation (measured by pulse oximeter) during resting \< 90%.
• Unable to stand for 5 minutes without an assistive device (length of a Wii Fit game)
• Uncontrolled acute medical/surgical, neurological or cardiovascular disease
• History of bone fracture or significant other systemic disease or surgery in the last six months
• Moderate to severe cognitive impairment (MOCA \<24/30)
• Specific to MRI participants: Self-reported presence of pacemaker, metal implants other than orthopedic implants, and/or Claustrophobia, cataract surgery (lens not compatible to the MRI confirmed by the MRI technician)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Kannan L, Sahu U, Subramaniam S, Mehta N, Kaur T, Hughes S, Bhatt T. Gaming-Based Tele-Exercise Program to Improve Physical Function in Frail Older Adults: Feasibility Randomized Controlled Trial. J Med Internet Res. 2024 Nov 27;26:e56810. doi: 10.2196/56810.

  PMID: 39602215 DERIVED

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Tanvi Bhatt
• Organization: University of Illinois at Chicago

tbhatt6@uic.edu

3123554443

Study Officials

• Tanvi S Bhatt, PT,MS,PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: January 10, 2021
• Primary Completion: December 5, 2022
• Study Completion: March 15, 2023
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Locations

US (1)