Clinical trial NCT01536756: Effectiveness of a Structured Physical Rehabilitation Program for Chinese Patients With Depressive Disorders
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorders
Keywords: Depressive disorder
exercise
pain
physical
psychological
Chinese
mild to severe depressive disorders
Lead sponsor: Kowloon Hospital, Hong Kong
Sponsor class: OTHER
Collaborators: name: Kwai Chung Hospital
First posted: 2012-02-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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:

1. The Physical Rehabilitation Program is effective in improving the physical fitness in Chinese patients with depressive disorders.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Able to read, write and understand Chinese;
3. Mentally capable of making written consent for participation of the study.

Exclusion Criteria:

1. Unstable medical and/or psychological states such as suicidal risk and aggressive impulses, or severe cognitive, language, or hearing deficits;
2. Orthopaedic problems or other diseases which limit physical fitness assessment.

Primary outcomes:
measure: Change from Baseline in Body Composition at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
measure: Change from Baseline in Flexibility at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
measure: Change from Baseline in Muscle Strength at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
measure: Change from Baseline in Muscular Endurance at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
measure: Change from Baseline in Cardiovascular Endurance at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
measure: Change from Baseline in Physical Functioning at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
Secondary outcomes:
measure: Change from Baseline in Depression, Anxiety and Stress at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
measure: Change from Baseline in Depression at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
measure: Change from Baseline in Self-esteem at 3 months and 12 months
timeFrame: Baseline, 3 months and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Physiotherapy Department, Kowloon Hospital
city: Hong Kong
country: China
facility: Physiotherapy Department, Kwai Chung Hospital
Study officials:
affiliation: Kowloon Hospital, Hong Kong
name: Mo Yee P Lau, DHSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.