Movement and Music Intervention for Individuals With Dementia

September 11, 2020 updated by: Deb Kegelmeyer, Ohio State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
ACTIVE_COMPARATOR: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Deb Kegelmeyer, DPT, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

December 30, 2017

Study Completion (ACTUAL)

December 30, 2017

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (ACTUAL)

April 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016H0211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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