Depressive DisordersNCT01536756
Effectiveness of a Structured Physical Rehabilitation Program for Chinese Patients With Depressive Disorders
A study testing Exercise Intervention -- Physical Rehabilitation Program in people with Depressive Disorders, run by Kowloon Hospital, Hong Kong at 2 sites in China.
Trial summary
Evidence shows that depression was found to be associated with physical inactivity and on the other hand, high prevalence of depression was also found in patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorders
- What is being tested?
- Exercise Intervention -- Physical Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2012to 31 Dec 2015
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages between 18 and 64 Chinese adults with diagnosed depressive disorders of mild to severe severity (Diagnostic code: F32.0 to F33.9 under International Classification of Diseases, 10th revision) as referred from the Department of Psychiatry of Kowloon Hospital or Kwai Chung Hospital;
- Able to read, write and understand Chinese;
- Mentally capable of making written consent for participation of the study.
Who cannot join
- Unstable medical and/or psychological states such as suicidal risk and aggressive impulses, or severe cognitive, language, or hearing deficits;
- Orthopaedic problems or other diseases which limit physical fitness assessment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Physiotherapy Department, Kowloon Hospital
Hong Kong
Physiotherapy Department, Kwai Chung Hospital
Hong Kong
About this study
Official title: A Single Blind Randomized Controlled Study Investigating the Effectiveness of a Structured Physical Rehabilitation Program on the Physical Fitness and Negative Psychological Symptoms for Chinese Patients With Mild to Severe Depressive Disorders
Evidence shows that depression was found to be associated with physical inactivity and on the other hand, high prevalence of depression was also found in patients with chronic pain. Structured physical rehabilitation program with exercises as main component and pain management provided by physiotherapy has been proved by overseas studies to be effective in reducing the psychological symptoms of depression through increasing the physical fitness and relieving the pain. Literatures also reported a strong sociocultural influence on the prevalence of depression and the manifestations of their clinical signs and symptoms in patients suffered from mental health problems between Chinese and Western societies. The benefits of physical rehabilitation program in the management of depression cannot be assumed in the Chinese population. The purpose of this study is to investigate the effectiveness of a structured "Physical Rehabilitation Program" for Chinese patients diagnosed with depressive disorder (mild to severe severity) on the physical fitness and negative psychological symptoms of the recruited patients.
The Hypothesis are:
- The Physical Rehabilitation Program is effective in improving the physical fitness in Chinese patients with depressive disorders.
- The Physical Rehabilitation Program is effective in alleviating the negative psychological symptoms in Chinese patients with depressive disorders.
Read the detailed description
Eighty-four Chinese patients who are diagnosed as depressive disorders with age between 18 and 64 years old, fulfilling the inclusion criteria (stated at the attached study proposal) will be recruited for a 12-week physical rehabilitation program with forty-two patients for the intervention group (n=42) and equal sample size for the control group (patient put on the waiting list for the Physical Rehabilitation Program). All patients will be allocated to either the intervention group or control group by computer generated block randomization with block size of 6 persons using StatsDirect Software, version 2.7.8. The subjects of the control group will be asked to maintain their usual activities while awaiting for the physical rehabilitation program at the 12-week waiting time. They will be allowed to receive any other usual medical services including social services and psychotherapy but not physiotherapy services. At the end of the 3rd month, the control group will be recruited into the Physical Rehabilitation Program. Patients in the control group will then join in as the intervention group and follow the intervention and assessment protocol. All the patients will be instructed not to disclose their grouping to the assessor. Sub-group analysis will be conducted for further in-depth analysis of the subjects in the intervention group having clinical manifestations of pain interference as triage by the 7 items in Brief Pain Inventory (BPI) - short form - Chinese version. Outcome measures on the physical and mental domains will be conducted: at baseline (T1-before commencement of program), end of the 3rd month (T2-end of program for intervention group; end of the waiting time of control group), 12 months (T3-one year long term follow-up for the intervention group). Validity and reliability of all the adopted outcome measures were reported in medical literatures. There is no reported harmful effect on all interventions and there is no pain or discomfort for all of the testing procedures. Physical outcome measures include body composition (body mass index, percentage of body fat); flexibility (sit and reach flexibility); muscular endurance (1-minute sit-up count); muscle strength (hand grip strength, isometric quadriceps strength); cardiovascular endurance (maximal oxygen consumption) and physical functioning (Brief Pain Inventory- Chinese version). Mental outcome measures include depression, anxiety \& stress (Depression, Anxiety, Stress Scale (DASS-21) - Chinese version); depression (Hamilton Depression Rating Scale- Chinese version) and self-esteem (Rosenberg Self-Esteem Scale- Chinese version). The findings will serve as pilot program for rolling out of the services for Chinese patients with depressive disorders to other clusters / hospital and reference base for future territory-wide profile study on this clientele and randomized controlled trials.
- Conditions
- Depressive Disorders
- Being tested
- Exercise Intervention -- Physical Rehabilitation Program, Wait List Control Group
- Keywords
- Depressive disorder, exercise, pain, physical, psychological, Chinese, mild to severe depressive disorders
- Medical subject headings
- Depressive Disorder, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention -- Physical Rehabilitation ProgramOther
The intervention group will participate in a "Physical Rehabilitation Program" which includes a 60-minute training session at a frequency of 3 times a week over a total of 12-week duration. The training session consists of 45 minutes of warm-up stretching and circuit training. This includes 3 stations of aerobic exercises for physical work up of different body parts, and 3 stations of strengthening exercises of major muscles groups at 3 sets of 10 repetitions. The final 15-minute training session will be the cooling down exercise with emphasis on stress management incorporating mindful breathing, stretching and body awareness exercise.
Wait List Control GroupOther
The subjects of the control group will be asked to maintain their usual activities while awaiting for the physical rehabilitation program at the 12-week waiting time. They will be allowed to receive any other usual medical services including social services and psychotherapy but not physiotherapy services. At the end of the 3rd month, the control group will be recruited into the Physical Rehabilitation Program. Patients in the control group will then join in as the intervention group and follow the intervention and assessment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention -- Physical Rehabilitation Program | Experimental | Not described Receives: Other: Exercise Intervention -- Physical Rehabilitation Program |
| Wait List Control Group | Other | Not described Receives: Other: Wait List Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Body Composition at 3 months and 12 months
Body Mass Index \& Percentage of Body Fat
Measured: Baseline, 3 months and 12 months
Change from Baseline in Flexibility at 3 months and 12 months
Sit and Reach Flexibility
Measured: Baseline, 3 months and 12 months
Change from Baseline in Muscle Strength at 3 months and 12 months
Hand Grip Strength \& Quadriceps Strength
Measured: Baseline, 3 months and 12 months
Change from Baseline in Muscular Endurance at 3 months and 12 months
One-Minute Sit-up Count
Measured: Baseline, 3 months and 12 months
Change from Baseline in Cardiovascular Endurance at 3 months and 12 months
Maximal Oxygen Consumption
Measured: Baseline, 3 months and 12 months
Change from Baseline in Physical Functioning at 3 months and 12 months
pain interference score of Brief Pain Inventory- Chinese version
Measured: Baseline, 3 months and 12 months
Secondary outcomes (3)
Change from Baseline in Depression, Anxiety and Stress at 3 months and 12 months
Depression Anxiety Stress Scale - 21 - Chinese Version
Measured: Baseline, 3 months and 12 months
Change from Baseline in Depression at 3 months and 12 months
Hamilton Depression Rating Scale- Chinese version
Measured: Baseline, 3 months and 12 months
Change from Baseline in Self-esteem at 3 months and 12 months
Rosenberg Self-Esteem Scale- Chinese version
Measured: Baseline, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
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 Depressive DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowloon Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kwai Chung Hospital
- Responsible party
- Principal investigator, Dr. Lau Mo Yee Polly, Kowloon Hospital, Hong Kong
- Investigators
- Mo Yee P Lau, DHSc, Principal investigator, Kowloon Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536756
- Sponsor's protocol ID
- KH-KCH-PSY-RCT
- Status last verified
- Jan 2020
- First submitted
- 10 Feb 2012
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Chau RMW, Tsui AYY, Wong EYW, Cheung EYY, Chan DYC, Lau PMY, Ng RMK. Effectiveness of a structured physical rehabilitation program on the physical fitness, mental health and pain for Chinese patients with major depressive disorders in Hong Kong - a randomized controlled trial with 9-month follow-up outcomes. Disabil Rehabil. 2022 Apr;44(8):1294-1304. doi: 10.1080/09638288.2020.1800833. Epub 2020 Aug 8.
PubMed 32772583
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind Randomized Controlled Study Investigating the Effectiveness of a Structured Physical Rehabilitation Program on the Physical Fitness and Negative Psychological Symptoms for Chinese Patients With Mild to Severe Depressive Disorders
- ClinicalTrials.gov ID
- NCT01536756
- Acronym / sponsor ID
- KH-KCH-PSY-RCT
- Conditions
- Depressive Disorders
- Keywords
- Depressive disorder, exercise, pain, physical, psychological, Chinese, mild to severe depressive disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kowloon Hospital, Hong KongUniversity, hospital or other
- Collaborators
- Kwai Chung Hospital
- Study start
- Feb 2012
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 22 Feb 2012 (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.
Evidence shows that depression was found to be associated with physical inactivity and on the other hand, high prevalence of depression was also found in patients with chronic pain. Structured physical rehabilitation program with exercises as main component and pain management provided by physiotherapy has been proved by overseas studies to be effective in reducing the psychological symptoms of depression through increasing the physical fitness and relieving the pain. Literatures also reported a strong sociocultural influence on the prevalence of depression and the manifestations of their clinical signs and symptoms in patients suffered from mental health problems between Chinese and Western societies. The benefits of physical rehabilitation program in the management of depression cannot be assumed in the Chinese population. The purpose of this study is to investigate the effectiveness of a structured "Physical Rehabilitation Program" for Chinese patients diagnosed with depressive disorder (mild to severe severity) on the physical fitness and negative psychological symptoms of the recruited patients.
The Hypothesis are:
- The Physical Rehabilitation Program is effective in improving the physical fitness in Chinese patients with depressive disorders.
- The Physical Rehabilitation Program is effective in alleviating the negative psychological symptoms in Chinese patients with depressive disorders.
Detailed description
Eighty-four Chinese patients who are diagnosed as depressive disorders with age between 18 and 64 years old, fulfilling the inclusion criteria (stated at the attached study proposal) will be recruited for a 12-week physical rehabilitation program with forty-two patients for the intervention group (n=42) and equal sample size for the control group (patient put on the waiting list for the Physical Rehabilitation Program). All patients will be allocated to either the intervention group or control group by computer generated block randomization with block size of 6 persons using StatsDirect Software, version 2.7.8. The subjects of the control group will be asked to maintain their usual activities while awaiting for the physical rehabilitation program at the 12-week waiting time. They will be allowed to receive any other usual medical services including social services and psychotherapy but not physiotherapy services. At the end of the 3rd month, the control group will be recruited into the Physical Rehabilitation Program. Patients in the control group will then join in as the intervention group and follow the intervention and assessment protocol. All the patients will be instructed not to disclose their grouping to the assessor. Sub-group analysis will be conducted for further in-depth analysis of the subjects in the intervention group having clinical manifestations of pain interference as triage by the 7 items in Brief Pain Inventory (BPI) - short form - Chinese version. Outcome measures on the physical and mental domains will be conducted: at baseline (T1-before commencement of program), end of the 3rd month (T2-end of program for intervention group; end of the waiting time of control group), 12 months (T3-one year long term follow-up for the intervention group). Validity and reliability of all the adopted outcome measures were reported in medical literatures. There is no reported harmful effect on all interventions and there is no pain or discomfort for all of the testing procedures. Physical outcome measures include body composition (body mass index, percentage of body fat); flexibility (sit and reach flexibility); muscular endurance (1-minute sit-up count); muscle strength (hand grip strength, isometric quadriceps strength); cardiovascular endurance (maximal oxygen consumption) and physical functioning (Brief Pain Inventory- Chinese version). Mental outcome measures include depression, anxiety \& stress (Depression, Anxiety, Stress Scale (DASS-21) - Chinese version); depression (Hamilton Depression Rating Scale- Chinese version) and self-esteem (Rosenberg Self-Esteem Scale- Chinese version). The findings will serve as pilot program for rolling out of the services for Chinese patients with depressive disorders to other clusters / hospital and reference base for future territory-wide profile study on this clientele and randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention -- Physical Rehabilitation Program | Experimental | Other: Exercise Intervention -- Physical Rehabilitation Program |
| Wait List Control Group | Other | Other: Wait List Control Group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages between 18 and 64 Chinese adults with diagnosed depressive disorders of mild to severe severity (Diagnostic code: F32.0 to F33.9 under International Classification of Diseases, 10th revision) as referred from the Department of Psychiatry of Kowloon Hospital or Kwai Chung Hospital;
- Able to read, write and understand Chinese;
- Mentally capable of making written consent for participation of the study.
Key exclusion criteria (2 listed)
- Unstable medical and/or psychological states such as suicidal risk and aggressive impulses, or severe cognitive, language, or hearing deficits;
- Orthopaedic problems or other diseases which limit physical fitness assessment.
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 |
|---|---|---|
| Exercise Intervention -- Physical Rehabilitation ProgramThe intervention group will participate in a "Physical Rehabilitation Program" which includes a 60-minute training session at a frequency of 3 times a week over a total of 12-week duration. The training session consists of 45 minutes of warm-up stretching and circuit training. This includes 3 stations of aerobic exercises for physical work up of different body parts, and 3 stations of strengthening exercises of major muscles groups at 3 sets of 10 repetitions. The final 15-minute training session will be the cooling down exercise with emphasis on stress management incorporating mindful breathing, stretching and body awareness exercise. | Other | Exercise Intervention -- Physical Rehabilitation Program |
| Wait List Control GroupThe subjects of the control group will be asked to maintain their usual activities while awaiting for the physical rehabilitation program at the 12-week waiting time. They will be allowed to receive any other usual medical services including social services and psychotherapy but not physiotherapy services. At the end of the 3rd month, the control group will be recruited into the Physical Rehabilitation Program. Patients in the control group will then join in as the intervention group and follow the intervention and assessment protocol. | Other | Wait List Control Group |
Primary outcome
Change from Baseline in Body Composition at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
Body Mass Index \& Percentage of Body Fat
Change from Baseline in Flexibility at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
Sit and Reach Flexibility
Change from Baseline in Muscle Strength at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
Hand Grip Strength \& Quadriceps Strength
Change from Baseline in Muscular Endurance at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
One-Minute Sit-up Count
Change from Baseline in Cardiovascular Endurance at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
Maximal Oxygen Consumption
Change from Baseline in Physical Functioning at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
pain interference score of Brief Pain Inventory- Chinese version
3 secondary outcomes
Change from Baseline in Depression, Anxiety and Stress at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
Change from Baseline in Depression at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
Change from Baseline in Self-esteem at 3 months and 12 months
Time frame: Baseline, 3 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 32772583Chau RMW, Tsui AYY, Wong EYW, Cheung EYY, Chan DYC, Lau PMY, Ng RMK. Effectiveness of a structured physical rehabilitation program on the physical fitness, mental health and pain for Chinese patients with major depressive disorders in Hong Kong - a randomized controlled trial with 9-month follow-up outcomes. Disabil Rehabil. 2022 Apr;44(8):1294-1304. doi: 10.1080/09638288.2020.1800833. Epub 2020 Aug 8.
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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.
Mo Yee P Lau, DHSc principal investigator
Kowloon Hospital, Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention -- Physical Rehabilitation Program in people with Depressive Disorders, run by Kowloon Hospital, Hong Kong at 2 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Body Composition at 3 months and 12 months (time frame: Baseline, 3 months and 12 months). The study lists 6 primary outcomes in all. 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 NCT01536756, 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 23 Jan 2020.