ExerciseREECONCT05462977
Rhythmically Entrained Exercise in Community-Dwelling Older Adults
A study testing Group exercise program in people with Exercise and Gait, run by University of North Carolina, Greensboro at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Gait, Cognitive Decline
- What is being tested?
- Group exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age younger than 55 or older than 99
- Severe anxiety or depression
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise, Gait, Cognitive Decline, Caregiver Burden, Cognitive Impairment, Dementia
- Being tested
- Group exercise program
- 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
- Medical subject headings
- Motor Activity, Cognitive Dysfunction, Caregiver Burden, Dementia, Alzheimer Disease, Psychological Well-Being, Depression, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group exercise programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group exercise with beat-accented synchronous music stimulation | Experimental | 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. Receives: Behavioral: Group exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of fall risks
Participants' fall risks will be measured by Timed Up \& Go Test
Measured: Baseline and change from baseline at month 5
Change of walking endurance
Participants' gait and walking endurance will be measured by 6-Minute Walk Test
Measured: Baseline and change from baseline at month 5
Change of balance control
Participants' balance control will be measured by 4-Stage Balance Test
Measured: Baseline and change from baseline at month 5
Change of lower body strength
Participants' lower body strength will be measured by 30-second Chair Stand Test
Measured: Baseline and change from baseline at month 5
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.
Measured: Baseline and change from baseline at month 5
Change of health-related quality of life
EuroQol Health Questionnaire
Measured: Baseline and change from baseline at month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 May 2022
- Primary completion28 Apr 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shin Park, PhD, Principal investigator, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462977
- Sponsor's protocol ID
- FY22-106
- Acronym
- REECO
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2021
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't have a plan to share IPD with other researchers at the moment.
Publications
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.2023.1224728. eCollection 2023.
PubMed 37671396
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rhythmically Entrained Exercise in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT05462977
- Acronym / sponsor ID
- REECO / FY22-106
- Conditions
- Exercise, Gait, Cognitive Decline, Caregiver Burden, Cognitive Impairment, Dementia
- Keywords
- Physical Activity, Rhythmic Entrainment, Synchronous Music, Rhythmic Auditory Stimulation, Rhythmic Auditory Cue, Gait Training, Mobility, Movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group exercise with beat-accented synchronous music stimulation | Experimental | Behavioral: Group exercise programParticipants 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. |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Age younger than 55 or older than 99
- Severe anxiety or depression
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group exercise programParticipants 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. | Behavioural | Group exercise with beat-accented synchronous music stimulation |
Primary outcome
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
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
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
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
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.
Change of health-related quality of life
Time frame: Baseline and change from baseline at month 5
EuroQol Health Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Results publication: PubMed 37671396Park 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.2023.1224728. eCollection 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. We don't have a plan to share IPD with other researchers at the moment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shin Park, PhD principal investigator
University of North Carolina, Greensboro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group exercise program in people with Exercise and Gait, run by University of North Carolina, Greensboro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of fall risks (time frame: Baseline and change from baseline at month 5). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.