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
Enrollment 192
Recruitment Details 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 Using the inclusion and exclusion criteria, 192 adult subjects were enrolled into the study
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 98 94
Completed 70 [1] 68 [2]
Not Completed 28 26
Reason Not Completed
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
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 98 94 192
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 94 participants 192 participants
74  (6.81) 74  (6.41) 74  (6.624)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 94 participants 192 participants
Female
11
  11.2%
6
   6.4%
17
   8.9%
Male
87
  88.8%
88
  93.6%
175
  91.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hong Kong Number Analyzed 98 participants 94 participants 192 participants
98 94 192
COPD-CSES   [1] 
Mean (Standard Deviation)
Unit of measure:  Rating score 0.2 to 1
Number Analyzed 98 participants 94 participants 192 participants
0.684  (0.165) 0.638  (0.152) 0.661  (0.160)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Likert scale
Number Analyzed 98 participants 94 participants 192 participants
6.86  (2.34) 6.53  (1.98) 6.70  (2.171)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Score from 0 to 100
Number Analyzed 98 participants 94 participants 192 participants
27.57  (19.71) 29.77  (19.94) 28.65  (19.80)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Score from 0 to 100
Number Analyzed 98 participants 94 participants 192 participants
43.08  (23.42) 50.75  (22.77) 46.84  (23.36)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Score from 0 to 100
Number Analyzed 98 participants 94 participants 192 participants
24.11  (17.37) 27.43  (20.02) 25.74  (18.74)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Score from 0 to 100
Number Analyzed 98 participants 94 participants 192 participants
30.44  (17.16) 34.89  (18.39) 32.61  (17.87)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Distance in meters
Number Analyzed 98 participants 94 participants 192 participants
320.2  (71.86) 312.1  (64.15) 316.22  (68.14)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 98 participants 94 participants 192 participants
2.26  (0.80) 2.05  (0.66) 2.15  (0.74)
[1]
Measure Description: Forced vital capacity is a component of lung function parameters measured using spirometry
FEV1   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 98 participants 94 participants 192 participants
1.23  (0.45) 1.10  (0.45) 1.16  (0.46)
[1]
Measure Description: Forced expiratory volume in one second ; component of lung function parameters measured by spirometry
FEV1% Pred   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of predicted normal values
Number Analyzed 98 participants 94 participants 192 participants
63.1  (22.11) 56.38  (23.81) 59.82  (23.15)
[1]
Measure Description: Pred FEV1 percent predicted normal values ; component of lung function parameters measured by spirometry
1.Primary Outcome
Title Self Efficacy :COPD Self Efficacy Scale (CSES)
Hide Description 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
Time Frame Change in CSES at 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat was used in the analysis
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: rating score of 0.2 to 1
0.733  (0.143) 0.685  (0.137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments Regression coefficients from ANCOVA for Tai Chi intervention (PRP as reference) at 6 months after adjusted for baseline value of the outcome variable, age, sex, BMI, smoking and education
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.017
Confidence Interval (2-Sided) 95%
-0.046 to 0.012
Estimation Comments [Not Specified]
2.Primary Outcome
Title Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)
Hide Description 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.
Time Frame Change in SEMSOB at 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Pulmonary Rehabilitation Program PRP+Tai Chi
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.13  (1.98) 7.03  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, PRP+Tai Chi
Comments power0.80 for a medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for baseline values, age, sex, education, BMI and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.005
Confidence Interval (2-Sided) 95%
-0.438 to 0.447
Parameter Dispersion
Type: Standard Deviation
Value: 0.442
Estimation Comments [Not Specified]
3.Primary Outcome
Title SGRQ HKC-Symptoms
Hide Description 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.
Time Frame 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.49  (19.53) 25.58  (20.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for a medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.869
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline values, age, sex, education, BMI and education
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.372
Confidence Interval (2-Sided) 95%
-4.061 to 4.805
Parameter Dispersion
Type: Standard Deviation
Value: 4.433
Estimation Comments [Not Specified]
4.Primary Outcome
Title SGRQ HKC-Activity
Hide Description 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.
Time Frame 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
41.04  (21.84) 44.92  (21.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for medium size effect at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline values, age, sex, BMI, education and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.295
Confidence Interval (2-Sided) 95%
-6.001 to 3.411
Parameter Dispersion
Type: Standard Deviation
Value: 4.706
Estimation Comments [Not Specified]
5.Primary Outcome
Title SGRQ HKC-Impact
Hide Description 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.
Time Frame 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.56  (19.36) 20.23  (19.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline values, age, sex, BMI, education and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.150
Confidence Interval (2-Sided) 95%
-6.627 to 2.327
Parameter Dispersion
Type: Standard Deviation
Value: 4.477
Estimation Comments [Not Specified]
6.Primary Outcome
Title SGRQ HKC Total
Hide Description 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.
Time Frame 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.72  (18.39) 28.60  (18.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.413
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline value, age, sex, BMI, education and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.690
Confidence Interval (2-Sided) 95%
-5.753 to 2.372
Parameter Dispersion
Type: Standard Deviation
Value: 4.062
Estimation Comments [Not Specified]
7.Secondary Outcome
Title 6 MWT in Meters
Hide Description 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.
Time Frame 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: meters
335.1  (68.49) 340.2  (74.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline value, age, sex, BMI, education and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.049
Confidence Interval (2-Sided) 95%
4.159 to 21.939
Parameter Dispersion
Type: Standard Deviation
Value: 8.89
Estimation Comments [Not Specified]
8.Secondary Outcome
Title FVC
Time Frame 6 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: liters
2.26  (0.77) 2.18  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.560
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline value, age, sex, BMI, education and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.042
Confidence Interval (2-Sided) 95%
-0.100 to 0.184
Parameter Dispersion
Type: Standard Deviation
Value: 0.226
Estimation Comments [Not Specified]
9.Secondary Outcome
Title FEV1
Hide Description Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry
Time Frame 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: liters
1.28  (0.51) 1.21  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.425
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline value, age, sex, BMI, education and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.037
Confidence Interval (2-Sided) 95%
-0.054 to 0.128
Parameter Dispersion
Type: Standard Deviation
Value: 0.088
Estimation Comments [Not Specified]
10.Secondary Outcome
Title FEV1% Pred
Hide Description Pred FEV1 percent predicted normal values;measured using spirometry
Time Frame 6 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Pulmonary Rehabilitation Program Tai Chi + PRP
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 98 94
Mean (Standard Deviation)
Unit of Measure: percentage of FEV1 predicted
66.2  (24.75) 62.52  (27.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pulmonary Rehabilitation Program, Tai Chi + PRP
Comments power of 0.80 for medium effect size at 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.528
Comments [Not Specified]
Method ANCOVA
Comments adjusted for baseline value, age, sex, BMI, education and smoking
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-3.5 to 6.8
Parameter Dispersion
Type: Standard Deviation
Value: 5.2
Estimation Comments [Not Specified]
Time Frame Both PRP and PRP+Tai chi were followed up to 6 months post-intervention.
Adverse Event Reporting Description "serious" and "other " adverse events were not assessed and collected
 
Arm/Group Title PRP + Tai Chi Pulmonary Rehabilitation Program PRP
Hide Arm/Group Description Tai Chi elements added to PRP program Subjects who received formal pulmonary rehabilitation program
All-Cause Mortality
PRP + Tai Chi Pulmonary Rehabilitation Program PRP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PRP + Tai Chi Pulmonary Rehabilitation Program PRP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PRP + Tai Chi Pulmonary Rehabilitation Program PRP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
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
EMail: 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