REECO: Rhythmically Entrained Exercise in Community-Dwelling Older Adults

Sponsor

University of North Carolina, Greensboro (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05462977

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers at the University of North Carolina at Greensboro conduct a single-arm intervention trial to investigate the efficacy of a music-based group exercise program for community-dwelling older adults. Up to forty participants will be recruited to participate in a music-based light-to-moderate intensity group exercise program for 24 weeks (30 - 40 min/day, up to 6 days/week), which is designed for older adults with or without functional limitations to exercise with chairs for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace. During the exercise sessions, participants will be trained to move in time with music playlists in synchronous tempos. Primary outcomes are cognitive performance, mobility, and health-related quality of life measured before and after the intervention. Secondary outcomes are adherence to the exercise program as a potential mediator of the treatment.

Condition or Disease	Intervention/Treatment	Phase
Exercise Gait Cognitive Decline Caregiver Burden Cognitive Impairment Dementia Alzheimer Disease Mild Cognitive Impairment Respite Care Mental Health Depression Music Therapy Psychosocial Intervention Cognition Geriatric Assessment Cognitive Dysfunction Cognitive Aging Outcome Assessment, Health Care Balance Fall Walking Affect Physical Exertion Memory Deficit Memory Disorders Memory Impairment Neuropsychological Tests Executive Function Middle Aged Healthy Aging Elderly	Behavioral: Group exercise program	N/A

Detailed Description

Researchers at the University of North Carolina at Greensboro are conducting a single-arm intervention trial to investigate the efficacy of a music-based group exercise program for community-dwelling older adults. Up to forty participants will be recruited to participate in a music-based light-to-moderate intensity group exercise program for 24 weeks (30 - 40 min/day, up to 6 days/week), which is designed for older adults with or without functional limitations to exercise with chairs for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace. During the exercise sessions, participants will be trained to move in time with music playlists in synchronous tempos. Primary outcomes are cognitive performance, mobility, and health-related quality of life measured before and after the intervention. Secondary outcomes are adherence to the exercise program as a potential mediator of the treatment. The research team aims to determine whether (1) a music-based light-to-moderate intensity group exercise intervention beneficially impacts mobility, cognitive function, and health-related quality of life in community-dwelling older adults; (2) the treatment effect is mediated by adherence to physical activity; and (3) the treatment effect is moderated by cognitive impairment or functional limitations.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants will be invited to participate in a music-based group exercise program for 24 weeks (30 - 40 min/day, up to 6 days/week).Participants will be invited to participate in a music-based group exercise program for 24 weeks (30 - 40 min/day, up to 6 days/week).

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Efficacy of Rhythmically Entrained Exercise in Community-Dwelling Older Adults

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group exercise with beat-accented synchronous music stimulation Participants will be asked to participate in a music-based group exercise program for 24 weeks (up to 6 days/week, 30 - 45 min/day), which is designed for older adults with functional limitations to safely exercise on a chair or in a supported standing posture for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace based on the tempo of the beat-accented synchronous music playlists.	Behavioral: Group exercise program Participants will be asked to join a music-based group exercise program for 24 weeks (up to 6 days/week, 30 - 45 min/day), which is designed for older adults with functional limitations to safely exercise on a chair or in a supported standing posture for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace in synchrony with music.

Arm

Intervention/Treatment

Experimental: Group exercise with beat-accented synchronous music stimulation

Participants will be asked to participate in a music-based group exercise program for 24 weeks (up to 6 days/week, 30 - 45 min/day), which is designed for older adults with functional limitations to safely exercise on a chair or in a supported standing posture for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace based on the tempo of the beat-accented synchronous music playlists.

Behavioral: Group exercise program

Participants will be asked to join a music-based group exercise program for 24 weeks (up to 6 days/week, 30 - 45 min/day), which is designed for older adults with functional limitations to safely exercise on a chair or in a supported standing posture for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace in synchrony with music.

Outcome Measures

Primary Outcome Measures

Change of fall risks [Baseline and change from baseline at 3 and 6 months]
Participants' fall risks will be measured by Timed Up & Go Test
Change of walking endurance [Baseline and change from baseline at 3 and 6 months]
Participants' gait and walking endurance will be measured by 6-Minute Walk Test
Change of balance control [Baseline and change from baseline at 3 and 6 months]
Participants' balance control will be measured by 4-Stage Balance Test
Change of lower body strength [Baseline and change from baseline at 3 and 6 months]
Participants' lower body strength will be measured by 30-second Chair Stand Test
Change of cognitive function [Baseline and change from baseline at 3 and 6 months]
Participants' cognitive function will be measured through Montreal Cognitive Assessment , Flanker Inhibitory Control and Attention test, and Pattern Comparison Processing Speed Test.
Change of health-related quality of life [Baseline and change from baseline at 3 and 6 months]
EuroQol Health Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

55 - 99 years old
Capable of being ambulatory with or without an assistive device.
No cardiac or pulmonary conditions or any neurological or musculoskeletal comorbidity or pain that would make light-intensity exercise dangerous, determined by the Physical Activity Readiness Questionnaire for Everyone or confirmed by their local medical practitioner if necessary.
Having adequate hearing for a conversation (including with hearing aids)
Capable of following the study procedures
No severe anxiety or depression