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Movement Intervention for Memory Enhancement (MIME)

Primary Purpose

Alzheimer Disease, Dementia, Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Dancing
Treadmill Walking
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social Dancing

Treadmill Walking

Arm Description

The program includes Fox-trot, Waltz, and Latin dances.

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.

Outcomes

Primary Outcome Measures

Executive Function (EF).
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.

Secondary Outcome Measures

Neuroplasticity.
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.

Full Information

First Posted
March 13, 2018
Last Updated
August 12, 2021
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03475316
Brief Title
Movement Intervention for Memory Enhancement
Acronym
MIME
Official Title
Social Dancing Intervention for Older Adults at High Risk of Alzheimer's Disease and Other Dementias: A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Cognitive Decline, Cognitive Impairment, Dementia, Alzheimer Type

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Dancing
Arm Type
Experimental
Arm Description
The program includes Fox-trot, Waltz, and Latin dances.
Arm Title
Treadmill Walking
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Dancing
Intervention Description
90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
Intervention Type
Behavioral
Intervention Name(s)
Treadmill Walking
Intervention Description
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 Measure Information:
Title
Executive Function (EF).
Description
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.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Neuroplasticity.
Description
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.
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Lifestyle Changes.
Description
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
Time Frame
Baseline, 6 months
Title
Gait.
Description
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.
Time Frame
Baseline, 6 months
Title
Balance
Description
Changes in balance will be measures at baseline and post-intervention using the Unipedal stance (measured in seconds). Higher time indicates better balance.
Time Frame
Baseline, 6 months
Title
Modified Katz Disability Scale.
Description
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.
Time Frame
Baseline, 6 months
Title
The Geriatric Depression Scale (GDS).
Description
Changes in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Verghese, MBBS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helena Blumen, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32741240
Citation
Blumen HM, Ayers E, Wang C, Ambrose AF, Verghese J. A social dancing pilot intervention for older adults at high risk for Alzheimer's disease and related dementias. Neurodegener Dis Manag. 2020 Aug;10(4):183-194. doi: 10.2217/nmt-2020-0002. Epub 2020 Aug 3.
Results Reference
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Movement Intervention for Memory Enhancement

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