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Movement and Music Intervention for Individuals With Dementia

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ClinicalTrials.gov Identifier: NCT03121950
Recruitment Status : Completed
First Posted : April 20, 2017
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Deb Kegelmeyer, Ohio State University

Brief 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 either a dance class or listen to live music. The study includes assessments of walking, balance and cognition.

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Dementia Other: Dance Other: music Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: No masking occured
Primary Purpose: Treatment
Official Title: Movement and Music Intervention for Individuals With Dementia
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Dance in dementia
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
Other: Dance
The primary intervention is a dance class

Experimental: Music and dementia
examine if listening to music improves mobility and/or cognition in individuals with dementia.
Other: music
the secondary intervention is listening to live music




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Score on the Montreal Cognitive Assessment [ Time Frame: 12 weeks ]
    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.


Other Outcome Measures:
  1. Change in Score on the Caregiver Burden Scale [ Time Frame: 12 weeks ]
    A questionnaire asking caregivers about the impact of caregiving on daily life. Scores range from 0-88, with higher scores indicating worse outcomes or more burden. Scores of 0-20 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, and 61-80 = severe burden.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of dementia
  • Mini-Mental State Examination score > 9
  • Age > 60 years
  • Able to follow simple instructions

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121950


Locations
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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Deb Kegelmeyer, DPT Ohio State University
  Study Documents (Full-Text)

Documents provided by Deb Kegelmeyer, Ohio State University:

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Responsible Party: Deb Kegelmeyer, Professor Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03121950     History of Changes
Other Study ID Numbers: 2016H0211
First Posted: April 20, 2017    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deb Kegelmeyer, Ohio State University:
dementia

Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders