AzTrials
AzTrials

Healthy Older AdultsNCT05134870

Mimic-game & Groove: A TeleXercise Intervention to Get Active & Get Healthy

A study testing Mimic- game and groove- Telerehabilitation in people with Healthy Older Adults, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The composite effect of reduced balance, cognition, gait abnormalities/gait disturbances, and physical activity in older adults leads to fear of falling and decreased participation in daily activities, resulting in reduced cardiovascular fitness and deconditioning. Read more about this study

Who is it for?
Ages 55 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Older Adults
What is being tested?
Mimic- game and groove- Telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
28 Aug 2020to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age group: Community-dwelling healthy older adults between the age group of 55 - 85 years
  • Participants without any history of fracture for the last 1 year
  • Should have either a desktop computer/laptop/tablet and a WIFI connection.
  • Absence of any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis.
  • No recent major surgery (< 6 months) or hospitalization (< 3 months)
  • Not on any sedative drugs
  • Can understand and communicate in English

Who cannot join

  • Participants will not proceed with the study if at baseline measurement HR > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age)
  • Inability to stand for at least 5 minutes without an assistive device (length of each exercise)
  • History of bone fracture or significant other systemic disease or surgery in the last six months
  • Uncontrolled acute medical, surgical, neurological or cardiovascular disease.
  • Moderate to severe cognitive impairment (MOCA <24/30)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

The composite effect of reduced balance, cognition, gait abnormalities/gait disturbances, and physical activity in older adults leads to fear of falling and decreased participation in daily activities, resulting in reduced cardiovascular fitness and deconditioning. Although many conventional balance and strength training programs have been implemented for older adults, these adults do not receive adequate practice dosage to make significant improvements, most likely due to lack of adherence to therapy and/or inadequate incorporation of all domains of the ICF model (body functions and structures, activities and participation) and lack of targeting cognitive-motor interference (deterioration of motor and/or cognitive function when both tasks are performed together). The use of TeleXercise via Tele rehabilitation has been found to be relatively enjoyable for older adults due to increased motivation and adherence to therapy, which led to the added improvement of physical and cognitive functioning. The overall aim of this pilot is to develop and test the Mimic-Me \& Groove TeleXercise platform and then evaluate the compliance and efficacy of the TeleXercise intervention compared to control group receiving standard of care (education on conventional exercise and fall prevention program) for older adults as well as its effect on enhancing balance, gait, and cognition, and physical activity. Investigators also hope that the net effect of improvement in these domains of health outcomes will result in pre and post improvement in endurance and cardiovascular function and reduction of fall risk and improved quality of life of older adults. The study investigates the efficacy of a TeleXercise intervention in older adults by demonstrating its feasibility, compliance rate and also determine the efficacy of the Mimic-Me \& Groove TeleXercise in improving health outcomes such as motor and cognitive functions, thereby reducing cognitive-motor interference. The study will also aim to determine the effectiveness of the TeleXercise in improving cardiovascular fitness and physical activity (PA) in older adults.

Read the detailed description

Aging results in neuromuscular deterioration, such as impaired balance control, gait instability, and worsening cognition with increasing evidence pointing to the over-reliance on cognitive function to perform even simple motor tasks. Such deterioration has been shown to affect daily functional activities, quality of life, and cardiovascular fitness, along with an increase in the risk of falling. Physical activity has been recommended as a means to slow down neuromuscular deterioration and enhance gait, stability, and cognition in older adults. Further, increased levels of physical activity have also demonstrated positive effects on cardiovascular fitness (heart rate variability, HRV).However, older adults do not meet the recommended daily requirement (of at least 5000 steps/day) due to reduced motivation and lack of compliance to physical activity regimen. The lack of compliance may emanate from difficulty to commute to outpatient rehabilitation centers, lack of involvement, and the decreased participatory nature of most conventional physical therapy interventions. As a result, there is the need to implement a home-based TeleXercise intervention for older adults. This TeleXercise intervention should be motivational and enjoyable with increased participation or involvement, while aiming to improve cognition, physical activity and balance for fall prevention in older adults. Exercise training provided via Tele rehabilitation, as an alternative therapy, has shown to increase balance control and gait as well as increase motivation among older adults. Further, our preliminary studies conducted in the laboratory has shown promising results on various alternative methods for rehabilitating older adults. Among which exergaming-based dance therapy has exhibited feasibility in improving balance, mobility and cardiovascular function, along with decreasing fall risk. Also, older adults exhibit deterioration of balance control and gait in dual-task conditions (i.e., simultaneous performance of two tasks). Few systematic reviews have emphasized on some task-specific exercises to improve balance control in older adults, such as single leg stance, modified tree pose etc. Thus, it could be postulated that older adults could benefit from an integrated comprehensive therapy program which incorporates various physical exercises, such as conventional methods of balance exercises, exergaming-based balance games, and dance with cognitive training. However, there is no data on the feasibility and effect of such comprehensive therapy on efficacy, compliance, balance, cognitive, gait and physical activity measures among older adults. Given that older adults lack compliance to therapy, investigators therefore, seek to examine the feasibility of a comprehensive TeleXercise-based intervention through the use of a comprehensive intervention protocol incorporating various physical exercises. Specifically, task-specific balance training provided via observing and imitating an exercise activates Action Observation Network system (AON) and other brain centers, which is known to improve balance control through increased plasticity of neural systems (mirror neurons) for optimal observation and actual performance of movement.

Aim1: The study will test the applicability, feasibility and compliance of TeleXercise intervention (N=17) to improve physical function and reduce fall-risk in community-dwelling older adults.

Hypothesis: Participants will tolerate the training paradigm and will demonstrate significant improvements in balance, gait, cardiovascular and cognitive performance under single and dual-task conditions. Participants will also demonstrate appropriate compliance (attend >24/30 session) and motivation (>Intrinsic Motivation Inventory scores) post-intervention.

Aim 2: To examine if the proposed TeleXercise intervention will lead to higher cognitive function post-intervention.

Hypothesis: Participants will show significantly greater global cognitive function, executive and working memory and decreased cognitive-motor load post-training compared to pre-training

Aim 3: To determine the effect of TeleXercise intervention on improving physical fitness (physical activity, PA) of community-based older adults.

Hypothesis 3: Post-training measures will depict a significant improvement in physical activity fitness.

Ancillary hypothesis: To determine if improved cognitive-motor function and physical fitness gained from a TeleXercise intervention will translate into improved falls efficacy, quality of life and physical activity post withdrawal of intervention with reduced fatigue and exertion.

Hypothesis: At 8 weeks (4 weeks post-intervention or withdrawal), participants will have retention of the post-training gains in single and dual-task conditions and cardiovascular fitness, which will translate into improved falls efficacy (improvement on Activities-specific Balance Confidence scale), quality of life (Older People's Quality of Life Questionnaire (OPQOL-35) and participation (improved Community Integration Scale) compared to their pre-training. Participants will also show improved falls efficacy translated to improved community ambulation (physical activity) and reduced fatigue and exertion (Borg Scale, NASA TLX scale)

Being tested
Mimic- game and groove- Telerehabilitation
Keywords
Tele-rehabilitation, TeleXercise, Mimic-Game-&Groove

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mimic- game and groove- TelerehabilitationBehavioural

    Also called Tele rehabilitation

    Participants will mimic the exergaming-based animation videos shown to them by the health coach. They will also wear a wearable device that will measure the heart rate and physical activity during the training. The intervention will have 12 sessions for 4 weeks, each session for 1.5 hours, including warm-ups and cool-down. Warm-up and cool down are for 20 minutes. Additionally, Participants are provided with a set of balance exercises which includes non-interactive balance games (stepping forward, backward, sideways), Tai-Chi, Weight shifting (to right leg, left leg and practice distributing equal weights on both the legs), Aerobic (stepping in place), dance, strength, and stretching

Study groups in NCT05134870
Study groupRoleWhat they receive
TeleXercise interventionExperimentalTeleXercise intervention will be delivered via exergaming-based animation videos combined with or without cognitive exercises by a health coach. Participants will need a computer/tablet/smart phone for the study. The health coach will launch the exercise application on their computer and share their screen with the participants. They have to mimic the exercises shown to them. The intervention will have 12 sessions for 4 weeks, each session for 1.5 hours, including warm-ups and cool-down. Warm-up and cool down are for 20 minutes. A wearable device provided will measure the heart rate and physical activity during the training. Participants are provided with a set of balance exercises which includes non-interactive balance games (stepping forward, backward, sideways), Tai-Chi, Weight shifting (to right leg, left leg and practice distributing equal weights on both the legs), Aerobic (stepping in place), dance, strength, and stretching
Receives: Behavioral: Mimic- game and groove- Telerehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in time during 30-second chair stand test.

    This test is conducted to assess leg strength and endurance.

    Measured: Change in time from pre-test (Week 0) to post-training (week 5)

  2. Change in time during four-step square test

    To test the dynamic balance and to assess the person's ability to step over objects forward, sideways, and backwards

    Measured: Change in time from pre-test (Week 0) to post-training (week 5)

  3. Change in time during Sharpened Romberg

    To assess the static balance of participants in sensory integration taxing condition

    Measured: Change in time from pre-test (Week 0) to post-training (week 5)

  4. Change in time during 2-minute step in place test

    To assess the cardiovascular exercise tolerance

    Measured: Change in time from pre-test (Week 0) to post-training (week 5)

  5. Change in time during One-legged Stance test

    To assess the static balance of participants in sensory integration taxing condition

    Measured: Change in time from pre-test (Week 0) to post-training (week 5)

  6. Change in time during Tinetti Performance Oriented Mobility Assessment

    To assess gait and balance together

    Measured: Change in time from pre-test (Week 0) to post-training (week 5)

Secondary outcomes (13)
  1. Change in correct responses during Letter Number sequencing test

    To assess cognitive performance

    Measured: Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  2. Change in correct responses during Visual stroop test

    To assess cognitive performance

    Measured: Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  3. Change in correct responses during Auditory stroop

    To assess cognitive performance

    Measured: Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  4. Change in correct response during Flanker inhibitory control and attention test

    To assess cognitive performance

    Measured: Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  5. Change in correct response during List Sorting Memory test

    To assess cognitive performance

    Measured: Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  6. Change in correct response during Dimensional Change card sort test

    To assess cognitive performance

    Measured: Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  7. Change in correct response during Pattern comparison Processing speed test

    Evaluates the processing speed of cognitive functioning.

    Measured: Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  8. Change in score of Physical Activity Scale for elderly

    To assess self-reported measure of physical activity

    Measured: Change in score from pre-test (Week 0) to post-training (week 5)

  9. Change in score of Activities Specific Balance Confidence scale (ABC scale)

    To assess self-reported measure of balance confidence. Scores range from 0-100. Score of zero represents no confidence, a score of 100 represents complete confidence.

    Measured: Change in score from pre-test (Week 0) to post-training (week 5)

  10. Change in score of Older People's Quality of Life Questionnaire (OPQOL-35)

    To assess their quality of life. There are 35 items, with scores ranging from 35- 175. Lesser scores indicate better quality of life, while higher scores indicate reduced quality of life.

    Measured: Change in score from pre-test (Week 0) to post-training (week 5)

  11. Change in score of Community Integration Scale (CIS).

    To assess their participation in the community. Total score range from 0-29. High scores indicate greater independence and social integration

    Measured: Change in score from pre-test (Week 0) to post-training (week 5)

  12. Change in score of Modified Borg Scale (MB)

    To determine the exertion and fatigue level during the training session and during pre-and post-assessment. Scores range from 0-10. Scale rates the difficulty breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal.

    Measured: Change in score from pre-test (Week 0) to post-training (week 5)

  13. Change in score of NASA Task Load Index scale (NASA-TLX)

    To determine the physical and cognitive load during the training session as well during pre- and post-assessment. The score ranges from1-20, where lowers scores indicate less demand, and higher scores indicate increased demand.

    Measured: Change in score from pre-test (Week 0) to post-training (week 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2021
  2. Study start28 Aug 2020
  3. Primary completion20 Feb 2023
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05134870
Sponsor's protocol ID
2020-0923
Status last verified
May 2024
First submitted
13 Aug 2021
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mimic- game and groove- Telerehabilitation in people with Healthy Older Adults, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in time during 30-second chair stand test. (time frame: Change in time from pre-test (Week 0) to post-training (week 5)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in