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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
12-step sitting Tai Chi Chuan
Control
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Tai Chi, dementia, caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hong Kong East Cluster, Hospital AuthorityRecruiting
  • Hong Kong West Cluster, Hospital AuthorityRecruiting
  • Kowloon West Cluster, Hospital AuthorityRecruiting
  • New Territories East Cluster, Hospital AuthorityRecruiting
  • New Territories West Cluster, Hospital Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

12-step sitting Tai Chi Chuan

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2014
Last Updated
May 5, 2016
Sponsor
The University of Hong Kong
Collaborators
Food and Health Bureau, Hong Kong, Chinese University of Hong Kong, University of Melbourne, National Ageing Research Institute, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT02132039
Brief Title
A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
Official Title
A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Food and Health Bureau, Hong Kong, Chinese University of Hong Kong, University of Melbourne, National Ageing Research Institute, Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Tai Chi, dementia, caregivers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12-step sitting Tai Chi Chuan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
12-step sitting Tai Chi Chuan
Intervention Description
The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan. Each session will last for an hour.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control consists of eight home-based sessions on useful health-care information. Each session will last for an hour.
Primary Outcome Measure Information:
Title
Change from baseline Hamilton Rating Scale for Depression in caregivers
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Berg Balance Scale in caregivers and care recipients
Description
Berg Balance Scale (BBS)
Time Frame
Week 12
Title
Mini Mental State Examination in caregivers and care recipients
Description
Global cognitive function will be measured by Mini Mental State examination (MMSE)
Time Frame
Week 12
Title
Quality of life in caregivers and care recipients
Description
SF-12 Health Survey (SF-12)
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Chi Chan
Phone
(+852) 2255 4486
Email
waicchan@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Chi Chan
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong East Cluster, Hospital Authority
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kong Hing Leung
Facility Name
Hong Kong West Cluster, Hospital Authority
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai Chi Chan
Phone
(+852) 2255 4486
Email
waicchan@hku.hk
First Name & Middle Initial & Last Name & Degree
Wai Chi Chan
Facility Name
Kowloon West Cluster, Hospital Authority
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Wat
Facility Name
New Territories East Cluster, Hospital Authority
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Lam
Facility Name
New Territories West Cluster, Hospital Authority
City
Hong Kong
Country
China
Individual Site Status
Completed

12. IPD Sharing Statement

Citations:
PubMed Identifier
27655115
Citation
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.
Results Reference
derived

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

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