ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Other: Tai chi + PRP
Other: PRP

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment and intervention part of the study took place between March 2011 and November 2011 with follow-up until May 2012. Subjects were recruited from four difference general out-patient clinics (GOPCs.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Using the inclusion and exclusion criteria, 192 adult subjects were enrolled into the study

Reporting Groups
  Description
Pulmonary Rehabilitation Program

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.

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

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.

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

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


Participant Flow:   Overall Study
    Pulmonary Rehabilitation Program   Tai Chi + PRP
STARTED   98   94 
COMPLETED   70 [1]   68 [2] 
NOT COMPLETED   28   26 
Withdrawal by Subject                27                24 
Death                1                2 
[1] 27 were lost to follow-up and 1 deceased
[2] 24 discontinued intervention and 2 deceased



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pulmonary Rehabilitation Program

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.

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

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.

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

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

Total Total of all reporting groups

Baseline Measures
   Pulmonary Rehabilitation Program   Tai Chi + PRP   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   94   192 
Age 
[Units: Years]
Mean (Standard Deviation)
 74  (6.81)   74  (6.41)   74  (6.624) 
Gender 
[Units: Participants]
     
Female   11   6   17 
Male   87   88   175 
Region of Enrollment 
[Units: Participants]
     
Hong Kong   98   94   192 
COPD-CSES [1] 
[Units: Rating score 0.2 to 1]
Mean (Standard Deviation)
 0.684  (0.165)   0.638  (0.152)   0.661  (0.160) 
[1] COPD Self-efficacy scale is a 34-item questionnaire which measures a person's confidence in managing or avoiding breathing difficulties in a number of situations categorized under 5 factors or condition. It consists of Likert scale with 5 responses ranging from "1" -not at all confident" to "5" - very confident" with higher scores representing higher self efficacy. In this study, a rating score which takes account of items that may not be applicable to the patient by reporting the average score based on the number of items answered. Minimum score 0.2 to maximum score of 1(higher self-efficacy)
SEMSOB [1] 
[Units: Likert scale]
Mean (Standard Deviation)
 6.86  (2.34)   6.53  (1.98)   6.70  (2.171) 
[1] Self-efficacy for managing shortness of breath 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 indication greater self efficacy.
SGRQ HKC Symptom [1] 
[Units: Score from 0 to 100]
Mean (Standard Deviation)
 27.57  (19.71)   29.77  (19.94)   28.65  (19.80) 
[1] The Saint George Respiratory Questionnaire (SGRQ HKC) is a Hong Kong Chinese validated version of a disease specific measure of health status applicable for use in COPD patients. It consists of 50 items with 76 weighted responses and has three component scores: symptoms, activity and impact. SGRQ HKC Symptom score is calculated by dividing the summed weights by adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptom score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HK-Activity [1] 
[Units: Score from 0 to 100]
Mean (Standard Deviation)
 43.08  (23.42)   50.75  (22.77)   46.84  (23.36) 
[1] The Saint George Respiratory Questionnaire (SGRQ HKC) is a Hong Kong Chinese validated version of a disease specific measure of health status applicable for use in COPD patients.It consists of 50 items with 76 weighted responses and has three component scores: symptoms, activity and impact. SGRQ HKC-Activity score is calculated by dividing the summed weights by adjusted maximum possible weight for that component and expressing the result as a percentage. Score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HKC-Impact [1] 
[Units: Score from 0 to 100]
Mean (Standard Deviation)
 24.11  (17.37)   27.43  (20.02)   25.74  (18.74) 
[1] The Saint George Respiratory Questionnaire (SGRQHKC) is a Hong Kong Chinese validated version of a disease specific measure of health status applicable for use in COPD patients. It consists of 50 items with 76 weighted responses and has three component scores: symptoms, activity and impact. SGRQ HKC-Impact score is calculated by dividing the summed weights by adjusted maximum possible weight for that component and expressing the result as a percentage. Score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ-HKC Total [1] 
[Units: Score from 0 to 100]
Mean (Standard Deviation)
 30.44  (17.16)   34.89  (18.39)   32.61  (17.87) 
[1] SGRQ HKC-total is the total score calculated from all three components (Symptom, activity and impact)by summing all positive responses in the questionnaire and expressing the result as a percentage of the total weight for the questionnaire. SGRQ total score also range from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
6 MWT [1] 
[Units: Distance in meters]
Mean (Standard Deviation)
 320.2  (71.86)   312.1  (64.15)   316.22  (68.14) 
[1] The 6 minute walking distance test measured the self paced distance that a patient could quickly walk on a flat, hard surface in a period of 6 minutes.
FVC [1] 
[Units: Liters]
Mean (Standard Deviation)
 2.26  (0.80)   2.05  (0.66)   2.15  (0.74) 
[1] Forced vital capacity is a component of lung function parameters measured using spirometry
FEV1 [1] 
[Units: Liters]
Mean (Standard Deviation)
 1.23  (0.45)   1.10  (0.45)   1.16  (0.46) 
[1] Forced expiratory volume in one second ; component of lung function parameters measured by spirometry
FEV1% Pred [1] 
[Units: Percentage of predicted normal values]
Mean (Standard Deviation)
 63.1  (22.11)   56.38  (23.81)   59.82  (23.15) 
[1] Pred FEV1 percent predicted normal values ; component of lung function parameters measured by spirometry


  Outcome Measures

1.  Primary:   Self Efficacy :COPD Self Efficacy Scale (CSES)   [ Time Frame: Change in CSES at 6 months post-intervention ]

2.  Primary:   Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)   [ Time Frame: Change in SEMSOB at 6 months post-intervention ]

3.  Primary:   SGRQ HKC-Symptoms   [ Time Frame: 6 months post-intervention ]

4.  Primary:   SGRQ HKC-Activity   [ Time Frame: 6 months post-intervention ]

5.  Primary:   SGRQ HKC-Impact   [ Time Frame: 6 months post-intervention ]

6.  Primary:   SGRQ HKC Total   [ Time Frame: 6 months post-intervention ]

7.  Secondary:   6 MWT in Meters   [ Time Frame: 6 months post-intervention ]

8.  Secondary:   FVC   [ Time Frame: 6 months post intervention ]

9.  Secondary:   FEV1   [ Time Frame: 6 months post-intervention ]

10.  Secondary:   FEV1% Pred   [ Time Frame: 6 months post-intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There was high attrition rate of 28% which further contributed to our small sample size with wide 95% confidence interval of several outcome variables results.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Lorna Ng
Organization: Kwong Wah Hospital
phone: (852) 23322311
e-mail: ngl@ha.org.hk



Responsible Party: Lorna Ventura Ng, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT01259245     History of Changes
Other Study ID Numbers: HHSRF08091291
First Submitted: December 3, 2010
First Posted: December 14, 2010
Results First Submitted: October 2, 2012
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013