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A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia

A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02132039
Enrollment
272
Registered
2014-05-06
Start date
2014-05-31
Completion date
2017-03-31
Last updated
2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Tai Chi, dementia, caregivers

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)

Interventions

OTHER12-step sitting Tai Chi Chuan

The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan. Each session will last for an hour.

OTHERControl

The control consists of eight home-based sessions on useful health-care information. Each session will last for an hour.

Sponsors

Food and Health Bureau, Hong Kong
CollaboratorOTHER_GOV
Chinese University of Hong Kong
CollaboratorOTHER
University of Melbourne
CollaboratorOTHER
National Ageing Research Institute, Australia
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Hamilton Rating Scale for Depression in caregiversWeek 12The 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

MeasureTime frameDescription
Berg Balance Scale in caregivers and care recipientsWeek 12Berg Balance Scale (BBS)
Mini Mental State Examination in caregivers and care recipientsWeek 12Global cognitive function will be measured by Mini Mental State examination (MMSE)
Quality of life in caregivers and care recipientsWeek 12SF-12 Health Survey (SF-12)

Countries

China

Contacts

Primary ContactWai Chi Chan
waicchan@hku.hk(+852) 2255 4486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026