- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475316
Movement Intervention for Memory Enhancement (MIME)
Social Dancing Intervention for Older Adults at High Risk of Alzheimer's Disease and Other Dementias: A Pilot Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Social dancing is a complex sensorimotor rhythmic activity integrating physical, cognitive and social elements with the potential to ameliorate a wide range of physical and cognitive impairments in older individuals at risk of Alzheimer's disease (AD) and related dementias. The few extant studies report that dancing stimulates multiple cognitive processes, including attention, processing speed, and executive function, but these discoveries were made in small samples, lacking control conditions, and did not investigate the underlying biological mechanisms.
Executive function (EF) is an umbrella term for the management of cognitive processes, including working memory, reasoning, task flexibility, and problem solving that are central to planning, goal-directed action, and coordination of daily activities. Impairment of EF and related processes such as processing speed and attention is seen in normal aging as well as early in dementia, and is associated with difficulty in performing daily activities and increased risk of adverse events such as falls. Encouragingly, aerobic exercise is reported to enhance cognition, especially EF. Cognitively impaired seniors fall more, and have higher prevalence and severity of balance and gait problems than cognitively intact fallers. Given social dancing's multimodal cognitive and physical benefits; it may help maintain mobility and reduce falls in individuals at risk for dementia. In support, the investigators reported that older social dancers had better balance and gait than non-dancers.
The investigators propose a 6-month pilot single blind, randomized clinical trial (RCT) comparing social dancing (ballroom dancing) versus active control (walking) in 32 older adults at high risk of dementia. The overall hypothesis is that social dancing in cognitively vulnerable seniors will induce neuroplasticity that will enhance cognitive processes and improving everyday behaviors. The objective for this pilot trial is to obtain preliminary data on intervention effects (trajectory and asymptote) on EF to design a full-scale RCT.
Social dancing appeals to older adults, has intrinsic value, is enjoyable, and has high potential for sustainability. This trial is novel and high risk, but will provide the evidence base to develop a definitive full-scale RCT to support or refute prescription of social dancing to prevent cognitive decline in older adults at high risk of AD and related dementias.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 65 and older
- A score of ≤ 6 on the Memory Impairment Screen or ≥ 1 on the AD-8
- Plan to be in area for next year or more
- English speaking
- Willing to complete an Functional Magnetic Resonance Imaging (MRI)
Exclusion Criteria:
- Presence of dementia based on previous physician diagnosis of dementia or dementia diagnosed by the study clinician at initial visit.
- Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease.
- Mobility limitations solely due to musculoskeletal or cardiovascular conditions that prevent participation in the intervention programs.
- Any medical condition or chronic medication use (e.g., neuroleptics) in the judgment of the screening clinician that will compromise safety or affect cognitive functioning.
- Terminal illness with life expectancy less than 12 months.
- Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or Amyotrophic lateral sclerosis).
- Severe auditory or visual loss.
- Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.
- Either participation in competitive dancing or recreational dancing at a frequency >1/month in the past six months.
- Participation in other interventional study that overlaps with intervention period of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Social Dancing
The program includes Fox-trot, Waltz, and Latin dances.
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90-min dance sessions twice weekly for 6-months.
The session includes warm-up, dance and cool down.
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ACTIVE_COMPARATOR: Treadmill Walking
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
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Each session starts with 5-10 minutes of warm-up walking at comfortable speed.
Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive Function (EF).
Time Frame: Baseline, 6 months
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Improvement in EF will be measured through a composite score from 3 tests.
(1) The Digit Symbol Substitution test is a measure of attention and speed of processing.
Scoring is based on the total number of correct responses generated over 90 seconds.
Higher values reflect better outcome.
(2) Flanker Test is a measure of speed of processing, attention and inhibitory control.
Scoring is based on accuracy and reaction time.
Lower values reflect better outcome.
(3) Walking While Talking (repeating alternating letters of the alphabet) gait speed (centimeters/second) will be measured using a electronic walkway system.
Higher values reflect better outcome.
The scores on the 3 tests are standardized and summed to obtain a single z-score.
The Z-score indicates the number of standard deviations away from the mean of the study population and a value of 0 is equal to the mean.
Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
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Baseline, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuroplasticity.
Time Frame: Baseline, 6 months
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Functional Magnetic Resonance Imaging will be used to investigate neuroplasticity under three conditions: 'imagined Walking While Talking' task, Digit Symbol Substitution test and Flanker interference tests.
Functional activation/deactivation patterns recorded by Functional Magnetic Resonance Imaging in response to the three tests will be examined within each participant before and after the intervention.
The values measured as factor scores reflect change in functional activation/deactivation covariance patterns from pre to post intervention as a function intervention (social dancing vs. treadmill walking).
Larger absolute values reflect more change in functional activation/deactivation covariance patterns from pre to post intervention on each of the three tasks.
There is no set minimum and maximum values of the scale.
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Baseline, 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lifestyle Changes.
Time Frame: Baseline, 6 months
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Lifestyle changes will be measured at baseline and post-intervention through the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire.
CHAMPS scale measures weekly frequency/week of moderate-intensity exercise-related activities.
Scores range from 0 to 133 with higher score indicating more exercise
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Baseline, 6 months
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Gait.
Time Frame: Baseline, 6 months
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Changes in gait speed will be measured at baseline and post-intervention through a quantitative gait mat.
Gait is measured in centimeters per second and higher values indicate faster walking speed.
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Baseline, 6 months
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Balance
Time Frame: Baseline, 6 months
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Changes in balance will be measures at baseline and post-intervention using the Unipedal stance (measured in seconds).
Higher time indicates better balance.
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Baseline, 6 months
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Modified Katz Disability Scale.
Time Frame: Baseline, 6 months
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Changes in function assessed by 4 key activities of daily living tasks-bathing, dressing, walking, and transferring.
Scores range from 0 to 8 with higher scores indicating worse outcome.
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Baseline, 6 months
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The Geriatric Depression Scale (GDS).
Time Frame: Baseline, 6 months
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Changes in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).
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Baseline, 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Helena Blumen, PhD, Albert Einstein College Of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-8942
- 1R21AG057586-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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