Aerobic Dance Training in Small Vessel Disease

NCT02730065 | Unknown DMC

• 1 other identifier: 03140936
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: Cerebral small vessel disease (SVD) is associated with age-related disabilities including dementia, depression, physical and functional impairment. Chinese are more prone to developing SVD than Caucasians. Physical exercise may improve multiple negative consequences associated with SVD. Objective and hypothesis to be tested: To examine the effects of a 24-week structured aerobic dance training on cognition, mood, physical and daily functions in stroke and dementia free older adults with SVD, and whether such effects are mediated through improved cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired in SVD. Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic dance training upon cognition, mood, physical and daily functions on 110 community dwelling, stroke- and dementia-free persons aged ≥65 with MRI evidence of significant SVD, defined as the presence of multiple (≥2) lacunes and/or early confluent or confluent WML. Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured therapist-led group aerobic dance training with home practice or simple stretching plus health education control group. Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using Transcranial Doppler at baseline, weeks 12, 24 and 36. Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed using mixed effects models. Mediation effects of CVR between aerobic dance training and treatment outcomes tested using mediation models. Expected results: In persons with significant SVD, aerobic dance training improves cognitive, mood, physical and daily functions and such effects are mediated by changes in CVR.

Conditions

Cerebrovascular Disease

Keywords

Cerebral small vessel disease; Lifestyle modification; Physical activity; Primary prevention; Aerobic dance; Cognition; Depression; Activities of daily living; Cerebral autoregulation

Outcome Measures

Primary Outcomes (6)

• Cognition assessed by the 30-minute protocol of the National Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocol summary score

  Change from baseline to week 24

• Depressive symptoms evaluated the Geriatric Depression Scale

  Change from baseline to week 24

• Physical balance measured by the Mini-Balance Evaluation Systems Test

  Change from baseline to week 24

• Functional mobility measured by the Timed-up-and-go test

  Change from baseline to week 24

• Walking capacity assessed by the 6-minute walk test

  Change from baseline to week 24

• Daily functioning evaluated by the Lawton's Instrumental Activities of Daily Living

  Change from baseline to week 24

Secondary Outcomes (2)

• Cerebral vasomotor reactivity measured by Pulsatility Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler

  Change from baseline to week 24

• Cerebral vasomotor reactivity measured by Breath Holding Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler

  Change from baseline to week 24

Other Outcomes (1)

• Number of participants with adverse events or serious adverse events

  Throughout the entire study period up to 36 weeks

Study Arms (2)

Structured Aerobic Dance Training Group

ACTIVE COMPARATOR

Active intervention will last for 24 weeks and consists of 60-minute/session, which includes 10 minutes warm-up, 40 minutes of dancing and 10 minutes of cool down. In groups of 5, participants will practice the dance led by a physiotherapist once per week for the first 2 months and twice per week for 3rd to 6th month.

Behavioral: Structured Aerobic Dance Training Group

Stretching plus education

PLACEBO COMPARATOR

Participants in the control group will receive a weekly 3-hour group-based (group of 5 participants) programme containing stretching exercise, stress reduction and health education on dementia and stroke prevention for 6 months. The programme consists of low-intensity seated stretching, psychoeducation on stress management, various relaxation methods with practice as well as education on the causes, identification, treatment and prevention of stroke and dementia. Benefits of physical exercise will also be discussed but will its weight will be evenly balanced with other forms of evidence-based preventive strategies.

Behavioral: Stretching plus education

Interventions

Structured Aerobic Dance Training Group BEHAVIORAL

Systematic physical activity

Structured Aerobic Dance Training Group

Stretching plus education BEHAVIORAL

Weekly group based stretching with psychoeducation and health education

Stretching plus education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65
• Community dwelling
• Presence of significant SVD, defined by the presence of multiple (≥2) lacunar infarcts and/or a rating of ≥2 (i.e. beginning confluence of lesions to diffuse involvement of lesions in periventricular and/or deep white matter) of WML using the Age-related White Matter Changes (ARWMC) Scale on MRI
• Presence of good temporal window on at least one side for TCD evaluation
• Written informed consent given

You may not qualify if:

• History of stroke
• Dementia, determined by a score on Cantonese MMSE less than education adjusted cutoff score for dementia or history of dementia diagnosis
• Comorbidity with medical conditions affecting the central nervous system or cerebral white matter
• Inadequately controlled psychiatric disorders affecting cognition and mood
• Physical or sensory impediments hindering participation in cognitive assessment or exercise training.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (2)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Neurology Clinical Research Centre, CUHK

Shatin, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders; Cerebral Small Vessel Diseases; Motor Activity; Depression

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Adrian Wong, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Wong, PhD

CONTACT

852-25587122; adrianwong@cuhk.edu.hk

Pauline Wing Lam Kwan, MSoSc

CONTACT

852-26352160; paulinekwan@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: April 6, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

HK (2)