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

NCT01536756 | Completed

• 1 other identifier: KH-KCH-PSY-RCT
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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

Conditions

Depressive Disorders

Keywords

Depressive disorder; exercise; pain; physical; psychological; Chinese; mild to severe depressive disorders

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in Body Composition at 3 months and 12 months

  Body Mass Index \& Percentage of Body Fat

  Baseline, 3 months and 12 months

• Change from Baseline in Flexibility at 3 months and 12 months

  Sit and Reach Flexibility

  Baseline, 3 months and 12 months

• Change from Baseline in Muscle Strength at 3 months and 12 months

  Hand Grip Strength \& Quadriceps Strength

  Baseline, 3 months and 12 months

• Change from Baseline in Muscular Endurance at 3 months and 12 months

  One-Minute Sit-up Count

  Baseline, 3 months and 12 months

• Change from Baseline in Cardiovascular Endurance at 3 months and 12 months

  Maximal Oxygen Consumption

  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

  Baseline, 3 months and 12 months

Secondary Outcomes (3)

• Change from Baseline in Depression, Anxiety and Stress at 3 months and 12 months

  Baseline, 3 months and 12 months

• Change from Baseline in Depression at 3 months and 12 months

  Baseline, 3 months and 12 months

• Change from Baseline in Self-esteem at 3 months and 12 months

  Baseline, 3 months and 12 months

Study Arms (2)

Exercise Intervention -- Physical Rehabilitation Program

EXPERIMENTAL

Other: Exercise Intervention -- Physical Rehabilitation Program

Wait List Control Group

OTHER

Other: Wait List Control Group

Interventions

Exercise Intervention -- Physical Rehabilitation Program OTHER

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.

Exercise Intervention -- Physical Rehabilitation Program

Wait List Control Group OTHER

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.

Wait List Control Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowloon Hospital, Hong Kong: lead
• Kwai Chung Hospital: collaborator

Study Sites (2)

Physiotherapy Department, Kowloon Hospital

Hong Kong, China

Location

Physiotherapy Department, Kwai Chung Hospital

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 32772583 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mo Yee P Lau, DHSc

  Kowloon Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cluster Manager (Physiotherapy), Kowloon Central Cluster

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 22, 2012
• Study Start: February 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

CN (2)