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Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for Chronic Obstructive Pulmonary Disease Patients in Primary Health Care (COPD)

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ClinicalTrials.gov Identifier: NCT01259245
Recruitment Status : Completed
First Posted : December 14, 2010
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Lorna Ventura Ng, Kwong Wah Hospital

Brief Summary:
The purpose of this study was to compare the self-efficacy and quality of life parameters of Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation with and without Tai Chi elements incorporated in the exercise component in a General Out-patient setting.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Tai chi + PRP Other: PRP Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tai chi + PRP
Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.
Other: Tai chi + PRP
The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise
Other Name: Tai chi elements added to pulmonary rehabilitation program

Other: PRP
Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Other Name: Formal pulmonary rehabilitation program

Active Comparator: PRP
PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.
Other: PRP
Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
Other Name: Formal pulmonary rehabilitation program




Primary Outcome Measures :
  1. Self Efficacy :COPD Self Efficacy Scale (CSES) [ Time Frame: Change in CSES at 6 months post-intervention ]
    34 item questionnaire consisting of likert scale with 5 responses ranging from "1" indicating " not at all confident" to "5" indicating " very confident" with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as "not at all confident and 1 as "very confident". The validated Chinese version of CSES was also used

  2. Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB) [ Time Frame: Change in SEMSOB at 6 months post-intervention ]
    The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients' overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.

  3. SGRQ HKC-Symptoms [ Time Frame: 6 months post-intervention ]
    SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.

  4. SGRQ HKC-Activity [ Time Frame: 6 months post-intervention ]
    SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.

  5. SGRQ HKC-Impact [ Time Frame: 6 months post-intervention ]
    SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.

  6. SGRQ HKC Total [ Time Frame: 6 months post-intervention ]
    SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.


Secondary Outcome Measures :
  1. 6 MWT in Meters [ Time Frame: 6 months post-intervention ]
    The 6 minute walking test ( 6MWT) was conducted according to protocol recommended by American Thoracic Society (ATS) guidelines to measure functional exercise capacity.This test measured the self paced distance in meters that a patient could quickly walk on a flat, hard surface in a period of 6 minutes.

  2. FVC [ Time Frame: 6 months post intervention ]
    Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry

  3. FEV1 [ Time Frame: 6 months post-intervention ]
    Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry

  4. FEV1% Pred [ Time Frame: 6 months post-intervention ]
    Pred FEV1 percent predicted normal values;measured using spirometry



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. . Previous diagnosis of COPD
  2. . Absence of bronchiectasis, bronchiolitis obliterans, panbronchiolitis and asthma
  3. . Medical Research Council(MRC)Dyspnea score > 2 using the 1-5 scale version
  4. .Willing to participate and able to give consent

Exclusion Criteria:

  1. . Patients with poor mobility, i.e. wheelchair bound; or
  2. . Patients with severe comorbidities, including acute myocardial infarction in preceding 6 months; or
  3. . Patients with severe hearing impairment or cognitive impairment; or
  4. . Patient unwilling to participate and unable to give consent

Information from the National Library of Medicine

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): NCT01259245


Locations
China
Kwong Wah Hospital General Out-patient Clinic
Hong Kong SAR, China
Sponsors and Collaborators
Kwong Wah Hospital
Investigators
Principal Investigator: lorna Ng, doctor Kwong Wah Hospital

Responsible Party: Lorna Ventura Ng, Senior Medical Officer, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT01259245     History of Changes
Other Study ID Numbers: HHSRF08091291
First Posted: December 14, 2010    Key Record Dates
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Lorna Ventura Ng, Kwong Wah Hospital:
Chronic obstructive pulmonary disease COPD
pulmonary rehabilitation program PRP
Tai chi

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases