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Rhythmically Entrained Exercise in Community-Dwelling Older Adults (REECO)

Primary Purpose

Exercise, Gait, Cognitive Decline

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group exercise program
Sponsored by
University of North Carolina, Greensboro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise focused on measuring Physical Activity, Rhythmic Entrainment, Synchronous Music, Rhythmic Auditory Stimulation, Rhythmic Auditory Cue, Gait Training, Mobility, Movement, Perceived Exertion, Musical Pleasure, Groove, Memory, Executive Function, Older Adults

Eligibility Criteria

55 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

  • Age younger than 55 or older than 99
  • Individuals with severe anxiety or depression

Sites / Locations

  • UNC Greensboro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group exercise with beat-accented synchronous music stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Change of fall risks
Participants' fall risks will be measured by Timed Up & Go Test
Change of walking endurance
Participants' gait and walking endurance will be measured by 6-Minute Walk Test
Change of balance control
Participants' balance control will be measured by 4-Stage Balance Test
Change of lower body strength
Participants' lower body strength will be measured by 30-second Chair Stand Test
Change of cognitive function
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
EuroQol Health Questionnaire

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
June 22, 2023
Sponsor
University of North Carolina, Greensboro
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1. Study Identification

Unique Protocol Identification Number
NCT05462977
Brief Title
Rhythmically Entrained Exercise in Community-Dwelling Older Adults
Acronym
REECO
Official Title
Efficacy of Rhythmically Entrained Exercise in Community-Dwelling Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Greensboro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Physical Activity, Rhythmic Entrainment, Synchronous Music, Rhythmic Auditory Stimulation, Rhythmic Auditory Cue, Gait Training, Mobility, Movement, Perceived Exertion, Musical Pleasure, Groove, Memory, Executive Function, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be invited to participate in a music-based group exercise program for 20 weeks (30 - 40 min/day, up to 6 days/week).
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group exercise with beat-accented synchronous music stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of fall risks
Description
Participants' fall risks will be measured by Timed Up & Go Test
Time Frame
Baseline and change from baseline at month 5
Title
Change of walking endurance
Description
Participants' gait and walking endurance will be measured by 6-Minute Walk Test
Time Frame
Baseline and change from baseline at month 5
Title
Change of balance control
Description
Participants' balance control will be measured by 4-Stage Balance Test
Time Frame
Baseline and change from baseline at month 5
Title
Change of lower body strength
Description
Participants' lower body strength will be measured by 30-second Chair Stand Test
Time Frame
Baseline and change from baseline at month 5
Title
Change of cognitive function
Description
Participants' cognitive function will be measured through Montreal Cognitive Assessment , Flanker Inhibitory Control and Attention test, and Pattern Comparison Processing Speed Test.
Time Frame
Baseline and change from baseline at month 5
Title
Change of health-related quality of life
Description
EuroQol Health Questionnaire
Time Frame
Baseline and change from baseline at month 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin Park, PhD
Organizational Affiliation
University of North Carolina, Greensboro
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27412
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We don't have a plan to share IPD with other researchers at the moment.

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Rhythmically Entrained Exercise in Community-Dwelling Older Adults

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