DepressionNCT02132039
A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
A study testing 12-step sitting Tai Chi Chuan in people with Depression, run by The University of Hong Kong at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- 12-step sitting Tai Chi Chuan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 5 sitesChina
- Study dates
- May 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 4 recruiting
- Recruiting
Hong Kong East Cluster, Hospital Authority
Hong Kong
Kong Hing Leung
- Recruiting
Hong Kong West Cluster, Hospital Authority
Hong Kong
Wai Chi Chan, (+852) 2255 4486, waicchan@hku.hk
Wai Chi Chan
- Recruiting
Kowloon West Cluster, Hospital Authority
Hong Kong
Karen Wat
- Recruiting
New Territories East Cluster, Hospital Authority
Hong Kong
Linda Lam
- Completed
New Territories West Cluster, Hospital Authority
Hong Kong
About this study
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.
Read the 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:
- The structured home-based exercise programme will reduce caregiver depression. (Primary outcome)
- The home-based exercise will improve caregivers' cognitive performance, quality of life and balance ability at the end of the study. (Secondary outcome)
- 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)
- We also hypothesise that BDNF gene modulates mood changes in response to exercise intervention. (Secondary outcome)
- Conditions
- Depression
- Being tested
- 12-step sitting Tai Chi Chuan, Control
- Keywords
- Tai Chi, dementia, caregivers
- Medical subject headings
- Depression, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-step sitting Tai Chi ChuanOther
The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan. Each session will last for an hour.
ControlOther
The control consists of eight home-based sessions on useful health-care information. Each session will last for an hour.
| Study group | Role | What they receive |
|---|---|---|
| 12-step sitting Tai Chi Chuan | Active comparator | 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. Receives: Other: 12-step sitting Tai Chi Chuan |
| Control | Placebo comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (3)
Berg Balance Scale in caregivers and care recipients
Berg Balance Scale (BBS)
Measured: Week 12
Mini Mental State Examination in caregivers and care recipients
Global cognitive function will be measured by Mini Mental State examination (MMSE)
Measured: Week 12
Quality of life in caregivers and care recipients
SF-12 Health Survey (SF-12)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, Chinese University of Hong Kong, University of Melbourne, National Ageing Research Institute, Australia
- Responsible party
- Principal investigator, Dr. Chan Wai Chi, The University of Hong Kong
- Investigators
- Wai Chi Chan, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132039
- Sponsor's protocol ID
- 11121441
- Status last verified
- May 2016
- First submitted
- 28 Apr 2014
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27655115
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
- ClinicalTrials.gov ID
- NCT02132039
- Acronym / sponsor ID
- 11121441
- Conditions
- Depression
- Keywords
- Tai Chi, dementia, caregivers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, Chinese University of Hong Kong, University of Melbourne, National Ageing Research Institute, Australia
- Study start
- May 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The structured home-based exercise programme will reduce caregiver depression. (Primary outcome)
- The home-based exercise will improve caregivers' cognitive performance, quality of life and balance ability at the end of the study. (Secondary outcome)
- 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)
- We also hypothesise that BDNF gene modulates mood changes in response to exercise intervention. (Secondary outcome)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-step sitting Tai Chi Chuan | Active comparator | Other: 12-step sitting Tai Chi ChuanThe 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 comparator | Other: ControlWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-step sitting Tai Chi ChuanThe intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan. Each session will last for an hour. | Other | 12-step sitting Tai Chi Chuan |
| ControlThe control consists of eight home-based sessions on useful health-care information. Each session will last for an hour. | Other | Control |
Primary outcome
Change from baseline Hamilton Rating Scale for Depression in caregivers
Time frame: 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.
3 secondary outcomes
Berg Balance Scale in caregivers and care recipients
Time frame: Week 12
Mini Mental State Examination in caregivers and care recipients
Time frame: Week 12
Quality of life in caregivers and care recipients
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Derived from this study: PubMed 27655115Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Chi Chan principal investigator
The University of Hong Kong
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-step sitting Tai Chi Chuan in people with Depression, run by The University of Hong Kong at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wai Chi Chan ((+852) 2255 4486, waicchan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Hamilton Rating Scale for Depression in caregivers (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.