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

Healthy Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134870
• Other study ID #: 2020-0923
• Status: Completed
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 30, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age group: Community-dwelling healthy older adults between the age group of 55 - 85 years

2. Participants without any history of fracture for the last 1 year

3. Should have either a desktop computer/laptop/tablet and a WIFI connection.

4. Absence of any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis.

5. No recent major surgery (< 6 months) or hospitalization (< 3 months)

6. Not on any sedative drugs

7. Can understand and communicate in English

Exclusion Criteria:

1. Participants will not proceed with the study if at baseline measurement HR > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age)

2. Inability to stand for at least 5 minutes without an assistive device (length of each exercise)

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

4. Uncontrolled acute medical, surgical, neurological or cardiovascular disease.

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

Related Conditions & MeSH terms

• Healthy Older Adults

Intervention

Behavioral:
• Mimic- game and groove- Telerehabilitation
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

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in time during 30-second chair stand test.	This test is conducted to assess leg strength and endurance.	Change in time from pre-test (Week 0) to post-training (week 5)
Primary	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	Change in time from pre-test (Week 0) to post-training (week 5)
Primary	Change in time during Sharpened Romberg	To assess the static balance of participants in sensory integration taxing condition	Change in time from pre-test (Week 0) to post-training (week 5)
Primary	Change in time during 2-minute step in place test	To assess the cardiovascular exercise tolerance	Change in time from pre-test (Week 0) to post-training (week 5)
Primary	Change in time during One-legged Stance test	To assess the static balance of participants in sensory integration taxing condition	Change in time from pre-test (Week 0) to post-training (week 5)
Primary	Change in time during Tinetti Performance Oriented Mobility Assessment	To assess gait and balance together	Change in time from pre-test (Week 0) to post-training (week 5)
Secondary	Change in correct responses during Letter Number sequencing test	To assess cognitive performance	Change in number of correct response from pre-test (Week 0) to post-training (week 5)
Secondary	Change in correct responses during Visual stroop test	To assess cognitive performance	Change in number of correct response from pre-test (Week 0) to post-training (week 5)
Secondary	Change in correct responses during Auditory stroop	To assess cognitive performance	Change in number of correct response from pre-test (Week 0) to post-training (week 5)
Secondary	Change in correct response during Flanker inhibitory control and attention test	To assess cognitive performance	Change in number of correct response from pre-test (Week 0) to post-training (week 5)
Secondary	Change in correct response during List Sorting Memory test	To assess cognitive performance	Change in number of correct response from pre-test (Week 0) to post-training (week 5)
Secondary	Change in correct response during Dimensional Change card sort test	To assess cognitive performance	Change in number of correct response from pre-test (Week 0) to post-training (week 5)
Secondary	Change in correct response during Pattern comparison Processing speed test	Evaluates the processing speed of cognitive functioning.	Change in number of correct response from pre-test (Week 0) to post-training (week 5)
Secondary	Change in score of Physical Activity Scale for elderly	To assess self-reported measure of physical activity	Change in score from pre-test (Week 0) to post-training (week 5)
Secondary	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.	Change in score from pre-test (Week 0) to post-training (week 5)
Secondary	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.	Change in score from pre-test (Week 0) to post-training (week 5)
Secondary	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	Change in score from pre-test (Week 0) to post-training (week 5)
Secondary	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.	Change in score from pre-test (Week 0) to post-training (week 5)
Secondary	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.	Change in score from pre-test (Week 0) to post-training (week 5)