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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05462977
Other study ID # FY22-106
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date September 30, 2023

Study information

Verified date October 2023
Source University of North Carolina, Greensboro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 30, 2023
Est. primary completion date April 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Affect
  • Alzheimer Disease
  • Balance
  • Caregiver Burden
  • Cognition
  • Cognitive Aging
  • Cognitive Decline
  • Cognitive Dysfunction
  • Cognitive Impairment
  • Dementia
  • Depression
  • Elderly
  • Executive Function
  • Exercise
  • Fall
  • Gait
  • Geriatric Assessment
  • Healthy Aging
  • Memory Deficit
  • Memory Disorders
  • Memory Impairment
  • Mental Health
  • Middle Aged
  • Mild Cognitive Impairment
  • Music Therapy
  • Neuropsychological Tests
  • Outcome Assessment, Health Care
  • Physical Exertion
  • Psychosocial Intervention
  • Respite Care
  • Walking

Intervention

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.

Locations

Country Name City State
United States UNC Greensboro Greensboro North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

References & Publications (1)

Park KS, Buseth L, Hong J, Etnier JL. Music-based multicomponent exercise training for community-dwelling older adults with mild-to-moderate cognitive decline: a feasibility study. Front Med (Lausanne). 2023 Aug 21;10:1224728. doi: 10.3389/fmed.2023.12247 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of fall risks Participants' fall risks will be measured by Timed Up & Go Test Baseline and change from baseline at month 5
Primary Change of walking endurance Participants' gait and walking endurance will be measured by 6-Minute Walk Test Baseline and change from baseline at month 5
Primary Change of balance control Participants' balance control will be measured by 4-Stage Balance Test Baseline and change from baseline at month 5
Primary Change of lower body strength Participants' lower body strength will be measured by 30-second Chair Stand Test Baseline and change from baseline at month 5
Primary 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. Baseline and change from baseline at month 5
Primary Change of health-related quality of life EuroQol Health Questionnaire Baseline and change from baseline at month 5
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