A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
- Conditions
- Depression
- Interventions
- Other: 12-step sitting Tai Chi ChuanOther: Control
- Registration Number
- NCT02132039
- Lead Sponsor
- The University of Hong Kong
- 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.
- Detailed Description
The proposed study is a single-blind randomised controlled trial for two years. We will compare the efficacy of a home-based structured exercise programme (12-step sitting Tai Chi) for both carers and care recipients with a standard non-exercise social contact control in the treatment of depression among caregivers of persons with dementia. The study hypotheses include:
1. The structured home-based exercise programme will reduce caregiver depression. (Primary outcome)
2. The home-based exercise will improve caregivers' cognitive performance, quality of life and balance ability at the end of the study. (Secondary outcome)
3. The home-based exercise will improve the cognitive performance, quality of life and balance ability of persons with dementia at the end of the study. (Secondary outcome)
4. We also hypothesise that BDNF gene modulates mood changes in response to exercise intervention. (Secondary outcome)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 272
Caregivers
- 18 years of age and above
- Live with persons with dementia
- 15-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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12-step sitting Tai Chi Chuan 12-step sitting Tai Chi Chuan The 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 Control We 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.
- Primary Outcome Measures
Name Time Method Change from baseline Hamilton Rating Scale for Depression in caregivers Week 12 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.
- Secondary Outcome Measures
Name Time Method Mini Mental State Examination in caregivers and care recipients Week 12 Global cognitive function will be measured by Mini Mental State examination (MMSE)
Berg Balance Scale in caregivers and care recipients Week 12 Berg Balance Scale (BBS)
Quality of life in caregivers and care recipients Week 12 SF-12 Health Survey (SF-12)
Trial Locations
- Locations (5)
New Territories East Cluster, Hospital Authority
🇨🇳Hong Kong, China
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 West Cluster, Hospital Authority
🇨🇳Hong Kong, China