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

NCT ID: NCT04534686

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-10
• Study Completion Date: 2023-03-15

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.

Detailed Description

The population of adults aged 60 years and older has been growing with around half of the people older than 85 years estimated to be frail. Age-related changes in multiple systems affecting balance, mobility, muscle strength, motor processing, cognition, nutrition, endurance and physical activity (PA) results in frailty. Studies on frail older adults have reported improvement in mobility and functional level following exercise interventions. Regular physical activity in this population has helped improve cardiovascular conditioning and quality of life, thus allowing these frail older adults a chance at independent living in the community. In addition to physical comorbidities, the presence of psychosocial issues such as depression may act as a barrier to community participation. Several PA interventions have demonstrated limited long-term effect and sustainable behavioral change in this population. An evidence-based fall prevention program called Matter of Balance (MOB) was developed to reduce fall risk and improve physical function and maximize activity participation in older adults. Meanwhile, Exergaming, a task-specific interactive gaming, has been gaining attention as a novel therapeutic alternative that promotes motor recovery in healthy and disabled populations. Exergaming involves repetitive-task specific exercises with movement execution feedback and motivation provided in real time. Studies have shown Exergaming improved symmetrical weight shifting, multi-directional stepping, single-stance, rapid movement training and self-initiated postural weight shifts in the participants. This anticipatory postural control training helps significantly improve balance control and mobility. In addition to the physical function domains that underlie physical frailty, executive cognitive domain functions also predict late-life physiological impairments. Thus, we postulate that PA facilitated through Exergaming and accompanied by simultaneous cognitive training is a novel approach to counter and inhibit frailty associated with physical function and cognitive decline.

Aim 1: To test the feasibility (compliance and effectiveness) of cognitive-motor exergaming (CogXergaming) in the frail older adults and to compare the improvements in behavioral biomarkers in this group across balance, muscle fitness, cardiovascular fitness and global cognition to the group receiving the Matter of Balance training.

Hypothesis: Participants will respond well to CogXergaming training paradigm and demonstrate significant improvements in balance, muscular fitness, cardiovascular fitness and global cognition as compared to the Matter of Balance training group.

Aim 2: To examine the effect of CogXergaming on physical activity levels and quality of life measures post-intervention.

Hypothesis: The participants who received CogXergaming will demonstrate significant improvement in physical activity and quality of life post-training as compared to their own pre-training scores.

Aim 3: To examine the effect of CogXergaming structural and functional connectivity within the cognitive-motor areas pre and post training to establish effect size.

Hypothesis: Post-training, participants will demonstrate improved memory consolidation, attention, motor planning and execution compared to pre-training indicating improved functional connectivity within the cognitive-motor areas.

Conditions

Frail Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CogXergaming

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Matter of Balance Training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive training; Conventional training

Eligibility Criteria

Inclusion Criteria

1. Older adults aged 60 years or above

2. Walking speed <0.8m/s

3. Self-reported Physical activity <3 hours/week

4. Hand grip strength <30 kgs for men & <20 kgs for women

5. Not on any sedative drugs

6. Can understand & communicate in English

7. Ability to walk more than 30 feet with or without an assistive device

Exclusion Criteria

1. 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%.

2. Unable to stand for 5 minutes without an assistive device (length of a Wii Fit game)

3. Uncontrolled acute medical/surgical, neurological or cardiovascular disease

4. History of bone fracture or significant other systemic disease or surgery in the last six months

5. Moderate to severe cognitive impairment (MOCA <24/30)

6. 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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Tanvi Bhatt

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tanvi S Bhatt, PT,MS,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39602215 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-0280

Identifier Type: -

Identifier Source: org_study_id