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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorna Ventura Ng, Kwong Wah Hospital
ClinicalTrials.gov Identifier:
NCT01259245
First received: December 3, 2010
Last updated: March 2, 2013
Last verified: March 2013
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Other: Tai chi + PRP
Other: PRP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care

Resource links provided by NLM:


Further study details as provided by Kwong Wah Hospital:

Primary Outcome Measures:
  • Self Efficacy :COPD Self Efficacy Scale (CSES) [ Time Frame: Change in CSES at 6 months post-intervention ] [ Designated as safety issue: No ]
    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

  • Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB) [ Time Frame: Change in SEMSOB at 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • SGRQ HKC-Symptoms [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • SGRQ HKC-Activity [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • SGRQ HKC-Impact [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • SGRQ HKC Total [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    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:
  • 6 MWT in Meters [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • FVC [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry

  • FEV1 [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry

  • FEV1% Pred [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Pred FEV1 percent predicted normal values;measured using spirometry


Enrollment: 192
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lorna Ventura Ng, Senior Medical Officer, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT01259245     History of Changes
Other Study ID Numbers: HHSRF08091291
Study First Received: December 3, 2010
Results First Received: October 2, 2012
Last Updated: March 2, 2013
Health Authority: Hong Kong: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 02, 2014