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Movement and Music Intervention for Individuals With Dementia

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ClinicalTrials.gov Identifier: NCT03121950
Recruitment Status : Unknown
Verified April 2017 by Deb Kegelmeyer, Ohio State University.
Recruitment status was:  Recruiting
First Posted : April 20, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Deb Kegelmeyer, Ohio State University

Tracking Information
First Submitted Date  ICMJE April 10, 2017
First Posted Date  ICMJE April 20, 2017
Last Update Posted Date April 21, 2017
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Change in time to complete the Timed up and go cognitive [ Time Frame: 12 weeks ]
a measure of walking time while performing a concurrent cognitive task
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03121950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Change in score on the Montreal Cognitive Assessment [ Time Frame: 12 weeks ]
An assessment of overall cognitive status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2017)
change in score on the caregiver burden [ Time Frame: 12 weeks ]
a questionnaire asking caregivers about the impact of caregiving on daily life
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Movement and Music Intervention for Individuals With Dementia
Official Title  ICMJE Movement and Music Intervention for Individuals With Dementia
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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:
The primary assessor will be blinded to group
Primary Purpose: Treatment
Condition  ICMJE
  • Dementia With Lewy Bodies
  • Dementia
Intervention  ICMJE
  • Other: Dance
    The primary intervention is a dance class
  • Other: music
    the secondary intervention is listening to live music
Study Arms  ICMJE
  • Experimental: Dance in dementia
    examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
    Intervention: Other: Dance
  • Experimental: Music and dementia
    examine if listening to music improves mobility and/or cognition in individuals with dementia.
    Intervention: Other: music
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2018
Estimated Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of dementia
  • Mini-Mental State Examinationscore > 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03121950
Other Study ID Numbers  ICMJE 2016H0211
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deb Kegelmeyer, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deb Kegelmeyer, DPT Ohio State University
PRS Account Ohio State University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP