Dementia, Dementia With Lewy Bodies
Conditions
Keywords
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 a dance class. 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.
Interventions
OTHERDance
The primary intervention is a dance class
OTHERMusic
the secondary intervention is listening to live music
Sponsors
Ohio State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go Cognitive | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on the Montreal Cognitive Assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on the Caregiver Burden Scale | 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. |
Countries
United States
Participant flow
Pre-assignment details
1 participant was excluded due to not meeting criteria on minimum score required for participation on the Mini Mental Status Examination
Participants by arm
| Arm | Count |
|---|---|
| Dance in Dementia examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
Dance: The primary intervention is a dance class | 17 |
| Music and Dementia examine if listening to music improves mobility and/or cognition in individuals with dementia.
music: the secondary intervention is listening to live music | 3 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 11 | 2 |
Baseline characteristics
| Characteristic | Music and Dementia | Total | Dance in Dementia |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 20 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74 years STANDARD_DEVIATION 11.36 | 82.3 years STANDARD_DEVIATION 8.62 | 83.76 years STANDARD_DEVIATION 7.55 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 20 Participants | 17 Participants |
| Region of Enrollment United States | 3 participants | 20 participants | 17 participants |
| Sex: Female, Male Female | 2 Participants | 11 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 3 |
| other Total, other adverse events | 0 / 17 | 0 / 3 |
| serious Total, serious adverse events | 0 / 17 | 0 / 3 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dance in Dementia | Timed up and go Cognitive | -6.49 seconds | Standard Deviation 9.66 |
| Music and Dementia | Timed up and go Cognitive | -13.35 seconds | Standard Deviation 0 |
Secondary
Change in Score on the Montreal Cognitive Assessment
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dance in Dementia | Change in Score on the Montreal Cognitive Assessment | -1.5 score on a scale | Standard Deviation 2.07 |
| Music and Dementia | Change in Score on the Montreal Cognitive Assessment | 0 score on a scale | Standard Deviation 0 |
Other Pre-specified
Change in Score on the Caregiver Burden Scale
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dance in Dementia | Change in Score on the Caregiver Burden Scale | -5.17 score on a scale | Standard Deviation 8.51 |
| Music and Dementia | Change in Score on the Caregiver Burden Scale | -7 score on a scale | Standard Deviation 0 |