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Movement Intervention for Memory Enhancement (MIME)

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ClinicalTrials.gov Identifier: NCT03475316
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Joe Verghese, Albert Einstein College of Medicine

Brief Summary:
Dancing is a complex sensorimotor rhythmic activity that integrates cognitive, physical, and social components and is applicable to seniors with various fitness levels. Despite its popularity, there is a paucity of studies that have systematically examined the role of dancing in preventing or delaying cognitive decline in older adults at high risk for Alzheimer's disease and related dementias. This preliminary randomized clinical trial will help provide the evidence base to develop a definitive full-scale trial to support or refute prescription of social dancing to prevent further cognitive decline in older adults at high risk of Alzheimer's disease and related dementia.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Cognitive Decline Cognitive Impairment Dementia, Alzheimer Type Behavioral: Social Dancing Behavioral: Treadmill Walking Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Social Dancing Intervention for Older Adults at High Risk of Alzheimer's Disease and Other Dementias: A Pilot Study.
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Experimental: Social Dancing
The program includes Fox-trot, Waltz, and Latin dances.
Behavioral: Social Dancing
90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.

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.
Behavioral: Treadmill Walking
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).




Primary Outcome Measures :
  1. Executive Function (EF). [ Time Frame: 6 months ]
    Improvement in EF will be measured through a composite score from 3 tests (Digit Symbol Substitution test, Flanker Test and Walking While Talking test). The Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised) is a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Higher values reflect better outcome. The 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. Gait speed (centimeters/second) will be measured during walking while talking (repeating alternating letters of the alphabet) using an instrumented walkway (GAITRite® electronic walkway system). Higher values reflect better outcome. The scores on the 3 tests are standardized and then summed to obtain a single composite value for EF for each participant.


Secondary Outcome Measures :
  1. Neuroplasticity. [ Time Frame: 6 months ]
    Functional Magnetic Resonance Imaging will be used to investigate neuroplasticity under three conditions: 'imagined Walking While Talking' task, Digit Symbol Substitution test and Flanker 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.


Other Outcome Measures:
  1. Lifestyle changes. [ Time Frame: 6 months ]
    Lifestyle changes will be measured at baseline and post-intervention through the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire.

  2. Gait. [ Time Frame: 6 months ]
    Changes in gait performance will be measured at baseline and post-intervention through a quantitative gait mat.

  3. Balance [ Time Frame: 6 months ]
    Changes in balance will be measures at baseline and post-intervention using the Unipedal stance and trunk sway assessments

  4. Modified Katz Disability Scale. [ Time Frame: 6 months ]
    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.

  5. The Geriatric Depression Scale (GDS). [ Time Frame: 6 months ]
    Changes in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475316


Contacts
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Contact: Joe Verghese, MBBS (718) 430-3877 joe.verghese@einstein.yu.edu
Contact: Helena Blumen, PhD (718) 430-3810 helena.blumen@einstein.yu.edu

Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Emmeline Ayers, MPH    718-430-3835    emmeline.ayers@einstein.yu.edu   
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Joe Verghese, MBBS Albert Einstein College of Medicine
Principal Investigator: Helena Blumen, PhD Albert Einstein College of Medicine

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Responsible Party: Joe Verghese, Professor of Neurology & Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03475316     History of Changes
Other Study ID Numbers: 2018-8942
1R21AG057586-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders