Dementia With Lewy BodiesNCT03121950
Movement and Music Intervention for Individuals With Dementia
A study testing Dance and Music in people with Dementia With Lewy Bodies and Dementia, run by Ohio State University at 1 site in United States.
Trial summary
The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia With Lewy Bodies, Dementia
- What is being tested?
- Dance and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dementia
- Mini-Mental State Examination score > 9
- Age > 60 years
- Able to follow simple instructions
Who cannot join
- Unable to walk 10 feet unassisted
- Presence of orthopedic disorder that impacts walking
- Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition.
Read the detailed description
Dementia impacts 5%-7% of individuals >60 years old. It impacts the person's ability to perform work, care for him/herself and ultimately leads to physical disability. There is a high caregiver burden associated with dementia and many individuals require care in a long-term care facility. There is some emerging evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia. The study aims to recruit individuals with a diagnosis of dementia. Once enrolled participants will undergo assessment of walking, balance and cognition and then be asked to participate either in a dance class or to listen to live music. After 6 weeks and again at the end of the study (after 12 weeks) participants will undergo assessments of walking, balance and cognition.
- Conditions
- Dementia With Lewy Bodies, Dementia
- Being tested
- Dance, Music
- Keywords
- dementia
- Medical subject headings
- Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceOther
The primary intervention is a dance class
MusicOther
the secondary intervention is listening to live music
| Study group | Role | What they receive |
|---|---|---|
| Dance in dementia | Experimental | examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Receives: Other: Dance |
| Music and dementia | Active comparator | examine if listening to music improves mobility and/or cognition in individuals with dementia. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go Cognitive
The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes.
Measured: 12 weeks
Secondary outcomes (1)
Change in Score on the Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is an assessment of overall cognitive status. The range of scores is 0-30, with higher scores indicating better outcomes. Scores 26 or higher indicates normal cognitive function.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Apr 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be placed in one of two groups. One group will participate 2 times a week in a dance class. The other group will listen to live music once a week.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deb Kegelmeyer, Ohio State University
- Investigators
- Deb Kegelmeyer, DPT, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121950
- Sponsor's protocol ID
- 2016H0211
- Status last verified
- Sep 2020
- First submitted
- 10 Apr 2017
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement and Music Intervention for Individuals With Dementia
- ClinicalTrials.gov ID
- NCT03121950
- Acronym / sponsor ID
- 2016H0211
- Conditions
- Dementia With Lewy Bodies, Dementia
- Keywords
- dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Posted 20 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition.
Detailed description
Dementia impacts 5%-7% of individuals >60 years old. It impacts the person's ability to perform work, care for him/herself and ultimately leads to physical disability. There is a high caregiver burden associated with dementia and many individuals require care in a long-term care facility. There is some emerging evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia. The study aims to recruit individuals with a diagnosis of dementia. Once enrolled participants will undergo assessment of walking, balance and cognition and then be asked to participate either in a dance class or to listen to live music. After 6 weeks and again at the end of the study (after 12 weeks) participants will undergo assessments of walking, balance and cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be placed in one of two groups. One group will participate 2 times a week in a dance class. The other group will listen to live music once a week.
| Arm | Type | Receives |
|---|---|---|
| Dance in dementia | Experimental | Other: Danceexamine if participating in a dance class improves mobility and/or cognition in individuals with dementia. |
| Music and dementia | Active comparator | Other: Musicexamine if listening to music improves mobility and/or cognition in individuals with dementia. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of dementia
- Mini-Mental State Examination score > 9
- Age > 60 years
- Able to follow simple instructions
Key exclusion criteria (3 listed)
- Unable to walk 10 feet unassisted
- Presence of orthopedic disorder that impacts walking
- Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury
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 |
|---|---|---|
| DanceThe primary intervention is a dance class | Other | Dance in dementia |
| Musicthe secondary intervention is listening to live music | Other | Music and dementia |
Primary outcome
Timed up and go Cognitive
Time frame: 12 weeks
The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes.
1 secondary outcome
Change in Score on the Montreal Cognitive Assessment
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Deb Kegelmeyer, DPT principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance and Music in people with Dementia With Lewy Bodies and Dementia, run by Ohio State University 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 4 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 16 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Timed up and go Cognitive (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2020.