Effectiveness of a Structured Physical Rehabilitation Program for Chinese Patients With Depressive Disorders
Condition: Depressive Disorders
MeSH terms: Depressive Disorder; Depression
Study type: Interventional

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.
    

Intervention name(s): Exercise Intervention -- Physical Rehabilitation Program; Wait List Control Group
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive disorder; exercise; pain; physical; psychological; Chinese; mild to severe depressive disorders