Clinical trial NCT05134870: Mimic-game & Groove: A TeleXercise Intervention to Get Active & Get Healthy
Official title: Mimic-game & Groove: A TeleXercise Intervention to Get Active & Get Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Older Adults
Keywords: Tele-rehabilitation
TeleXercise
Mimic-Game-&Groove
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 32
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Change in time during 30-second chair stand test.
timeFrame: Change in time from pre-test (Week 0) to post-training (week 5)
measure: Change in time during four-step square test
timeFrame: Change in time from pre-test (Week 0) to post-training (week 5)
measure: Change in time during Sharpened Romberg
timeFrame: Change in time from pre-test (Week 0) to post-training (week 5)
measure: Change in time during 2-minute step in place test
timeFrame: Change in time from pre-test (Week 0) to post-training (week 5)
measure: Change in time during One-legged Stance test
timeFrame: Change in time from pre-test (Week 0) to post-training (week 5)
measure: Change in time during Tinetti Performance Oriented Mobility Assessment
timeFrame: Change in time from pre-test (Week 0) to post-training (week 5)
Secondary outcomes:
measure: Change in correct responses during Letter Number sequencing test
timeFrame: Change in number of correct response from pre-test (Week 0) to post-training (week 5)
measure: Change in correct responses during Visual stroop test
timeFrame: Change in number of correct response from pre-test (Week 0) to post-training (week 5)
measure: Change in correct responses during Auditory stroop
timeFrame: Change in number of correct response from pre-test (Week 0) to post-training (week 5)
measure: Change in correct response during Flanker inhibitory control and attention test
timeFrame: Change in number of correct response from pre-test (Week 0) to post-training (week 5)
measure: Change in correct response during List Sorting Memory test
timeFrame: Change in number of correct response from pre-test (Week 0) to post-training (week 5)
measure: Change in correct response during Dimensional Change card sort test
timeFrame: Change in number of correct response from pre-test (Week 0) to post-training (week 5)
measure: Change in correct response during Pattern comparison Processing speed test
timeFrame: Change in number of correct response from pre-test (Week 0) to post-training (week 5)
measure: Change in score of Physical Activity Scale for elderly
timeFrame: Change in score from pre-test (Week 0) to post-training (week 5)
measure: Change in score of Activities Specific Balance Confidence scale (ABC scale)
timeFrame: Change in score from pre-test (Week 0) to post-training (week 5)
measure: Change in score of Older People's Quality of Life Questionnaire (OPQOL-35)
timeFrame: Change in score from pre-test (Week 0) to post-training (week 5)
measure: Change in score of Community Integration Scale (CIS).
timeFrame: Change in score from pre-test (Week 0) to post-training (week 5)
measure: Change in score of Modified Borg Scale (MB)
timeFrame: Change in score from pre-test (Week 0) to post-training (week 5)
measure: Change in score of NASA Task Load Index scale (NASA-TLX)
timeFrame: Change in score from pre-test (Week 0) to post-training (week 5)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Tanvi S Bhatt, PhD
role: PRINCIPAL_INVESTIGATOR
References: