- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05462977
Rhythmically Entrained Exercise in Community-Dwelling Older Adults (REECO)
October 31, 2023 updated by: University of North Carolina, Greensboro
Efficacy of Rhythmically Entrained Exercise in Community-Dwelling Older Adults
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 20 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.
Study Overview
Status
Completed
Conditions
- Depression
- Cognitive Impairment
- Cognitive Dysfunction
- Dementia
- Alzheimer Disease
- Exercise
- Caregiver Burden
- Healthy Aging
- Fall
- Mild Cognitive Impairment
- Elderly
- Executive Function
- Gait
- Mental Health
- Cognitive Decline
- Memory Disorders
- Memory Impairment
- Walking
- Cognition
- Physical Exertion
- Music Therapy
- Geriatric Assessment
- Balance
- Affect
- Cognitive Aging
- Memory Deficit
- Middle Aged
- Psychosocial Intervention
- Neuropsychological Tests
- Respite Care
- Outcome Assessment, Health Care
Intervention / Treatment
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 20 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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Greensboro, North Carolina, United States, 27412
- UNC Greensboro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
- Mild to moderate cognitive impairment
Exclusion Criteria:
- Age younger than 55 or older than 99
- Severe anxiety or depression
- Severe cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of fall risks
Time Frame: Baseline and change from baseline at month 5
|
Participants' fall risks will be measured by Timed Up & Go Test
|
Baseline and change from baseline at month 5
|
Change of walking endurance
Time Frame: Baseline and change from baseline at month 5
|
Participants' gait and walking endurance will be measured by 6-Minute Walk Test
|
Baseline and change from baseline at month 5
|
Change of balance control
Time Frame: Baseline and change from baseline at month 5
|
Participants' balance control will be measured by 4-Stage Balance Test
|
Baseline and change from baseline at month 5
|
Change of lower body strength
Time Frame: Baseline and change from baseline at month 5
|
Participants' lower body strength will be measured by 30-second Chair Stand Test
|
Baseline and change from baseline at month 5
|
Change of cognitive function
Time Frame: Baseline and change from baseline at month 5
|
Participants' cognitive function will be measured through Montreal Cognitive Assessment , Flanker Inhibitory Control and Attention test, and Pattern Comparison Processing Speed Test.
|
Baseline and change from baseline at month 5
|
Change of health-related quality of life
Time Frame: Baseline and change from baseline at month 5
|
EuroQol Health Questionnaire
|
Baseline and change from baseline at month 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shin Park, PhD, University of North Carolina, Greensboro
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
April 28, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
October 13, 2021
First Submitted That Met QC Criteria
July 13, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Stress, Psychological
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Memory Disorders
- Caregiver Burden
Other Study ID Numbers
- FY22-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We don't have a plan to share IPD with other researchers at the moment.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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