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Trial Outcomes & Findings for Movement and Music Intervention for Individuals With Dementia (NCT NCT03121950)

NCT ID: NCT03121950

Last Updated: 2020-09-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-09-16

Participant Flow

1 participant was excluded due to not meeting criteria on minimum score required for participation on the Mini Mental Status Examination

Participant milestones

Participant milestones
Measure
Dance in Dementia
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
Music and Dementia
examine if listening to music improves mobility and/or cognition in individuals with dementia.
Overall Study
STARTED
17
3
Overall Study
COMPLETED
6
1
Overall Study
NOT COMPLETED
11
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Dance in Dementia
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
Music and Dementia
examine if listening to music improves mobility and/or cognition in individuals with dementia.
Overall Study
Withdrawal by Subject
11
2

Baseline Characteristics

Movement and Music Intervention for Individuals With Dementia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dance in Dementia
n=17 Participants
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class
Music and Dementia
n=3 Participants
examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
17 Participants
n=5 Participants
3 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Continuous
83.76 years
STANDARD_DEVIATION 7.55 • n=5 Participants
74 years
STANDARD_DEVIATION 11.36 • n=7 Participants
82.3 years
STANDARD_DEVIATION 8.62 • n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
2 Participants
n=7 Participants
11 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
1 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
17 Participants
n=5 Participants
3 Participants
n=7 Participants
20 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
17 participants
n=5 Participants
3 participants
n=7 Participants
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Dance in Dementia
n=6 Participants
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class
Music and Dementia
n=1 Participants
examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music
Timed up and go Cognitive
-6.49 seconds
Standard Deviation 9.66
-13.35 seconds
Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Dance in Dementia
n=6 Participants
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class
Music and Dementia
n=1 Participants
examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music
Change in Score on the Montreal Cognitive Assessment
-1.5 score on a scale
Standard Deviation 2.07
0 score on a scale
Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Dance in Dementia
n=6 Participants
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class
Music and Dementia
n=1 Participants
examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music
Change in Score on the Caregiver Burden Scale
-5.17 score on a scale
Standard Deviation 8.51
-7 score on a scale
Standard Deviation 0

Adverse Events

Dance in Dementia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Music and Dementia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deb Kegelmeyer

The Ohio State University

Phone: 614-293-0214

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place