A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
1 other identifier
interventional
272
1 country
5
Brief Summary
The study aims to compare the efficacy of a home-based structured exercise programme (12-step sitting Tai Chi) involving both persons with dementia and their caregivers with a standard non-exercise social contact control in treating depression among caregivers. The effects of exercise on their cognition, quality of life and balance ability are also assessed. We will also examine if BDNF polymorphisms modulate mood changes in response to exercise intervention. Focus groups will be organised at the end to find out the facilitators and barriers in taking up exercise. The findings may offer an avenue of intervention by providing a low cost, relatively safe and effective treatment for dementia caregivers, which may in turn benefit the persons with dementia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started May 2014
Typical duration for not_applicable depression
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMay 6, 2016
May 1, 2016
2.3 years
April 28, 2014
May 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Hamilton Rating Scale for Depression in caregivers
The proportion of participants who are classified as responders by Hamilton Rating Scale for Depression (HAM-D-17). HAM-D-17 is a widely used and reliable measure of depressive symptoms. The scores range from 0 to 52, with higher scores indicating greater depression severity. Response to intervention is defined as a reduction of HAM-D-17 total score by ≥50% from baseline to endpoint.
Week 12
Secondary Outcomes (3)
Berg Balance Scale in caregivers and care recipients
Week 12
Mini Mental State Examination in caregivers and care recipients
Week 12
Quality of life in caregivers and care recipients
Week 12
Study Arms (2)
12-step sitting Tai Chi Chuan
ACTIVE COMPARATORThe intervention is a simplified Tai Chi Chuan exercise, which consists of 12 steps, including weight shifting in different sitting positions, trunk and upper limb movements, and alternate thigh lift in a smooth and coordinated manner.
Control
PLACEBO COMPARATORWe provide participants in the control group with a level of social contact equivalent to the intervention group, which comprises structured conversations on topic other than physical activity.
Interventions
The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan. Each session will last for an hour.
The control consists of eight home-based sessions on useful health-care information. Each session will last for an hour.
Eligibility Criteria
You may qualify if:
- Caregivers
- years of age and above
- Live with persons with dementia
- item Geriatric Depression Scale (GDS) \>0 and \<8
- No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months
- Understand Chinese
- If they are on an antidepressant, they will not be included in the study unless they have been receiving pharmacological treatment on a steady dose for three months
- Care recipient
- Aged 60 years or above
- Dementia diagnosis confirmed by a physician
- Dependence in at least one Activities of daily living(ADL)
- Mini Mental State Examination (MMSE) \> 10
- No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months
You may not qualify if:
- Caregivers
- Presence of psychotic symptoms, imminently suicidal, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training
- Carers who are found to have mental conditions that warrants psychiatric assessment and/or treatment (e.g. GDS \>8, i.e. local cut-off score for significant depressive symptoms, or suicidal) will be referred to appropriate units for follow up
- Care recipient
- Presence of psychotic symptoms, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Food and Health Bureau, Hong Kongcollaborator
- Chinese University of Hong Kongcollaborator
- University of Melbournecollaborator
- National Ageing Research Institute, Australiacollaborator
Study Sites (5)
Hong Kong East Cluster, Hospital Authority
Hong Kong, China
Hong Kong West Cluster, Hospital Authority
Hong Kong, China
Kowloon West Cluster, Hospital Authority
Hong Kong, China
New Territories East Cluster, Hospital Authority
Hong Kong, China
New Territories West Cluster, Hospital Authority
Hong Kong, China
Related Publications (1)
Chan WC, Lautenschlager N, Dow B, Ma SL, Wong CS, Lam LC. A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial. Trials. 2016 Sep 21;17(1):460. doi: 10.1186/s13063-016-1582-z.
PMID: 27655115DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wai Chi Chan
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
April 28, 2014
First Posted
May 6, 2014
Study Start
May 1, 2014
Primary Completion
September 1, 2016
Study Completion
March 1, 2017
Last Updated
May 6, 2016
Record last verified: 2016-05