NCT03121950

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 a dance class. The study includes assessments of walking, balance and cognition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 20, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

April 10, 2017

Results QC Date

February 26, 2018

Last Update Submit

September 11, 2020

Conditions

Keywords

dementia

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Change in Score on the Montreal Cognitive Assessment

    12 weeks

Other Outcomes (1)

  • Change in Score on the Caregiver Burden Scale

    12 weeks

Study Arms (2)

Dance in dementia

EXPERIMENTAL

examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.

Other: Dance

Music and dementia

ACTIVE COMPARATOR

examine if listening to music improves mobility and/or cognition in individuals with dementia.

Other: Music

Interventions

DanceOTHER

The primary intervention is a dance class

Dance in dementia
MusicOTHER

the secondary intervention is listening to live music

Music and dementia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lewy Body DiseaseDementia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Our study had many limitations including significant barriers to recruitment and retention of participants. Because of this, we changed the design to a pretest-posttest pilot study and included data from a participant at 6 weeks in the manuscript.

Results Point of Contact

Title
Deb Kegelmeyer
Organization
The Ohio State University

Study Officials

  • Deb Kegelmeyer, DPT

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Clinical

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 20, 2017

Study Start

April 1, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

September 16, 2020

Results First Posted

June 20, 2019

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations