- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132039
A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wai Chi Chan
- Phone Number: (+852) 2255 4486
- Email: waicchan@hku.hk
Study Locations
-
-
-
Hong Kong, China
- Recruiting
- Hong Kong East Cluster, Hospital Authority
-
Principal Investigator:
- Kong Hing Leung
-
Hong Kong, China
- Recruiting
- Hong Kong West Cluster, Hospital Authority
-
Contact:
- Wai Chi Chan
- Phone Number: (+852) 2255 4486
- Email: waicchan@hku.hk
-
Principal Investigator:
- Wai Chi Chan
-
Hong Kong, China
- Recruiting
- Kowloon West Cluster, Hospital Authority
-
Principal Investigator:
- Karen Wat
-
Hong Kong, China
- Recruiting
- New Territories East Cluster, Hospital Authority
-
Principal Investigator:
- Linda Lam
-
Hong Kong, China
- Completed
- New Territories West Cluster, Hospital Authority
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan.
Each session will last for an hour.
|
Placebo Comparator: 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.
|
The control consists of eight home-based sessions on useful health-care information.
Each session will last for an hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale in caregivers and care recipients
Time Frame: Week 12
|
Berg Balance Scale (BBS)
|
Week 12
|
Mini Mental State Examination in caregivers and care recipients
Time Frame: Week 12
|
Global cognitive function will be measured by Mini Mental State examination (MMSE)
|
Week 12
|
Quality of life in caregivers and care recipients
Time Frame: Week 12
|
SF-12 Health Survey (SF-12)
|
Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wai Chi Chan, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11121441
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Lawson Health Research InstituteTerminated
Clinical Trials on 12-step sitting Tai Chi Chuan
-
Lidian ChenPeking University Third HospitalNot yet recruiting
-
Bai XiaorongActive, not recruiting
-
National Center for Complementary and Integrative...CompletedCancer | Cancer SurvivorUnited States
-
Anhui Medical UniversityCompletedRandomized Clinical Trial | Intestinal Flora | Exercise Intervention | Tai Chi ChuanChina
-
Lidian ChenPeking University Third HospitalNot yet recruiting
-
University Hospital, Clermont-FerrandUnknown
-
Lithuanian Sports UniversityCompletedHealthy Aging | Cognitive Function | Motor LearningLithuania
-
Federal University of PelotasNot yet recruiting
-
The Hong Kong Polytechnic UniversityFood and Health Bureau, Hong KongRecruitingSleep | Elderly | Mindfulness | Tai Chi ChuanHong Kong
-
Hospital de Clinicas de Porto AlegreCompletedAcute Myocardial Infarction