Clinical trial NCT03475316: Movement Intervention for Memory Enhancement
Official title: Social Dancing Intervention for Older Adults at High Risk of Alzheimer's Disease and Other Dementias: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Cognitive Decline
Cognitive Impairment
Dementia, Alzheimer Type
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-03-23
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Executive Function (EF).
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Neuroplasticity.
timeFrame: Baseline, 6 months
Other outcomes:
measure: Lifestyle Changes.
timeFrame: Baseline, 6 months
measure: Gait.
timeFrame: Baseline, 6 months
measure: Balance
timeFrame: Baseline, 6 months
measure: Modified Katz Disability Scale.
timeFrame: Baseline, 6 months
measure: The Geriatric Depression Scale (GDS).
timeFrame: Baseline, 6 months
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Joe Verghese, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Helena Blumen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.