Effectiveness of a Structured Physical Rehabilitation Program for Chinese Patients With Depressive Disorders
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ClinicalTrials.gov Identifier: NCT01536756 |
Recruitment Status
: Unknown
Verified February 2012 by Dr. Lau Mo Yee Polly, Kowloon Hospital, Hong Kong.
Recruitment status was: Recruiting
First Posted
: February 22, 2012
Last Update Posted
: February 27, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorders | Other: Exercise Intervention -- Physical Rehabilitation Program Other: Wait List Control Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | October 2013 |
Estimated Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Exercise Intervention -- Physical Rehabilitation Program |
Other: Exercise Intervention -- Physical Rehabilitation Program
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.
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No Intervention: Wait List Control Group |
Other: Wait List Control Group
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.
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- 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
- Change from Baseline in Depression, Anxiety and Stress at 3 months and 12 months [ Time Frame: Baseline, 3 months and 12 months ]Depression Anxiety Stress Scale - 21 - Chinese Version
- Change from Baseline in Depression at 3 months and 12 months [ Time Frame: Baseline, 3 months and 12 months ]Hamilton Depression Rating Scale- Chinese version
- Change from Baseline in Self-esteem at 3 months and 12 months [ Time Frame: Baseline, 3 months and 12 months ]Rosenberg Self-Esteem Scale- Chinese version

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536756
Contact: Mo Yee P Lau, DHSc | 852-31296051 | pmylau@ha.org.hk | |
Contact: Mei Wa R Chau, DHSc | 852-31297123 | chaumw@ha.org.hk |
China | |
Physiotherapy Department, Kowloon Hospital | Recruiting |
Hong Kong, China | |
Contact: Mo Yee P Lau, DHSc 852-31296051 pmylau@ha.org.hk | |
Principal Investigator: Mo Yee P Lau, DHSc | |
Sub-Investigator: Man Kin R Ng, MBChB, MSc | |
Sub-Investigator: Wai Kiu A Tsang, MBBS | |
Sub-Investigator: Kong Man Ng, MBChB, MSSc | |
Sub-Investigator: Chun Ting Chan, MBBS | |
Sub-Investigator: Mei Wa R Chau, DHSc | |
Sub-Investigator: Mei Yuk M Cheung Lam, MSSc | |
Sub-Investigator: Lai Wah F Tang, MSSc | |
Sub-Investigator: Yuk King P Lo, MHSc | |
Sub-Investigator: Wai Leung P Lau, MSc | |
Sub-Investigator: Sui Hing F Chan, BSc | |
Physiotherapy Department, Kwai Chung Hospital | Not yet recruiting |
Hong Kong, China | |
Contact: Wing Yee M Tung Lau, MSc 852-29588253 lauwym@ha.org.hk | |
Sub-Investigator: Hoi Shuen Z Yu, MBBS | |
Sub-Investigator: Wing Yee M Tung Lau, MSc |
Principal Investigator: | Mo Yee P Lau, DHSc | Kowloon Hospital, Hong Kong |
Responsible Party: | Dr. Lau Mo Yee Polly, Cluster Manager (Physiotherapy), Kowloon Central Cluster, Kowloon Hospital, Hong Kong |
ClinicalTrials.gov Identifier: | NCT01536756 History of Changes |
Other Study ID Numbers: |
KH-KCH-PSY-RCT |
First Posted: | February 22, 2012 Key Record Dates |
Last Update Posted: | February 27, 2012 |
Last Verified: | February 2012 |
Keywords provided by Dr. Lau Mo Yee Polly, Kowloon Hospital, Hong Kong:
Depressive disorder exercise pain physical |
psychological Chinese mild to severe depressive disorders |
Additional relevant MeSH terms:
Disease Depressive Disorder Depression Pathologic Processes |
Mood Disorders Mental Disorders Behavioral Symptoms |