NCT03475316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

March 28, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 10, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

March 13, 2018

Results QC Date

May 4, 2021

Last Update Submit

August 12, 2021

Conditions

Alzheimer DiseaseDementiaCognitive DeclineCognitive ImpairmentDementia, Alzheimer Type

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 6 months

Secondary Outcomes (1)

  • Neuroplasticity.

    Baseline, 6 months

Other Outcomes (5)

  • Lifestyle Changes.

    Baseline, 6 months

  • Gait.

    Baseline, 6 months

  • Balance

    Baseline, 6 months

  • +2 more other outcomes

Study Arms (2)

Social Dancing

EXPERIMENTAL

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

Behavioral: Social Dancing

Treadmill Walking

ACTIVE COMPARATOR

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

Interventions

Social DancingBEHAVIORAL

90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.

Social Dancing
Treadmill WalkingBEHAVIORAL

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).

Treadmill Walking

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

    PMID: 32741240BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Results Point of Contact

Title
Dr. Joe Verghese
Organization
Albert Einstein College of Medicine
joe.verghese@einsteinmed.org
718-430-3877

Study Officials

  • Joe Verghese, MBBS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Helena Blumen, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology & Medicine

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 23, 2018

Study Start

March 28, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 16, 2021

Results First Posted

August 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)