Effectiveness of a Structured Physical Rehabilitation Program for Chinese Patients With Depressive Disorders

Primary Outcome Measures:

• Change from Baseline in Body Composition at 3 months and 12 months [ Time Frame: Baseline, 3 months and 12 months ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  Sit and Reach Flexibility
  
  
• Change from Baseline in Muscle Strength at 3 months and 12 months [ Time Frame: Baseline, 3 months and 12 months ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  Maximal Oxygen Consumption
  
  
• Change from Baseline in Physical Functioning at 3 months and 12 months [ Time Frame: Baseline, 3 months and 12 months ] [ Designated as safety issue: No ]
  pain interference score of Brief Pain Inventory- Chinese version
  
  

Secondary Outcome Measures:

• Change from Baseline in Depression, Anxiety and Stress at 3 months and 12 months [ Time Frame: Baseline, 3 months and 12 months ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  Rosenberg Self-Esteem Scale- Chinese version
  
  

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.