Movement Intervention for Memory Enhancement (MIME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03475316|
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Dementia Cognitive Decline Cognitive Impairment Dementia, Alzheimer Type||Behavioral: Social Dancing Behavioral: Treadmill Walking||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|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|
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).
- 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.
- 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.
- 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.
- Gait. [ Time Frame: 6 months ]Changes in gait performance will be measured at baseline and post-intervention through a quantitative gait mat.
- Balance [ Time Frame: 6 months ]Changes in balance will be measures at baseline and post-intervention using the Unipedal stance and trunk sway assessments
- 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.
- 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).
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
|Contact: Joe Verghese, MBBS||(718) email@example.com|
|Contact: Helena Blumen, PhD||(718) firstname.lastname@example.org|
|United States, New York|
|Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Emmeline Ayers, MPH 718-430-3835 email@example.com|
|Principal Investigator:||Joe Verghese, MBBS||Albert Einstein College of Medicine|
|Principal Investigator:||Helena Blumen, PhD||Albert Einstein College of Medicine|