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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.
Subjects: 192 patients were enrolled and recruited from four General Out-patient clinics in Yau Tsim Mong and Wong Tai Sin districts.
Study Design: Prospective single blind randomized controlled trial
Subjects were randomized into Pulmonary rehabilitation program (PRP) group (n = 98) and Pulmonary rehabilitation program with Tai chi group (TC)(n=94). Details of PRP and PRP + Tai Chi will be discussed below.
Both groups will be given booklet on COPD information and management.
Randomization:
Computer generated pre-assigned randomization of subjects to group allocation is made after baseline assessment. At each stage, assessors for outcome measures and data collection are blinded to the patient's grouping. Patients, investigator and physiotherapist are open to the group allocation.
Standardized medical treatment:
All COPD patients are managed according to practical guidelines recommended by the Hospital Authority. Medical treatment is reviewed and changed if clinically appropriate. In response to an exacerbation, antibiotic is added if a respiratory infection is the cause and oral steroid may be prescribed if clinically indicated.
Measurement and Evaluation
Baseline assessment:
Reassessment done at 2 months and 6 months using:
Statistical methods
Descriptive statistics including mean, standard deviation, frequency and percentages were used to describe the demographic characteristics and summarize the baseline characteristics of the variables. Independent T-test was used to examine the difference in demographic characteristics and baseline outcome measures between the PRP and TC group. Paired T-test was performed to examine the differences of outcome measures, including spirometry, 6 MWT, SGRQ-HKC, CSES, SEMSOB before and after intervention program within group. Analysis of covariance(ANCOVA) were used to examine the differences of outcome variables between PRP and TC group adjusted for age, sex, body mass index BMI, smoking and education, with the corresponding baseline value as a covariate. A p-value of 0.05 ws used as the level of statistical significance. Confidence intervals ( 95%) of the mean differences between baseline and 6 months post intervention values were calculated to compare the effects with the minimum clinically important difference (MCID) for the SGRQ-HKC. All analyses were conducted using Statistical package for the Social Sciences SPSS version 16.0.
Pulmonary Rehabilitation Programme (PRP) Details :
The revised PRP consisted of 12 sessions (twice per week for 6 weeks) with 6-10 subjects per session. The standard content consists of physical training including warm up & cool down exercise and aerobic exercises.
For the PRP group, patients performed 5 minutes warm up exercises. Then 2 aerobic activities including treadmill exercise and lower limb ergometry exercise lasting 20 minutes each,were prescribed. 15 minutes rest were given between each exercise. After the aerobic exercises, 5 minutes cool down exercises, followed by 15 minutes of relaxation exercise was conducted before patients completed that session. Each session lasted for about 1 hour and 20 minutes.They were instructed to continue unsupervised home exercises consisting of 5 minutes of warm-up, 5 minutes of Thera-Band strengthening exercises, 30 minutes of aerobic exercises, 5 minutes cool down and 15 minutes of relaxation exercise for at least one hour 5-7 days/week.
For the PRP + Tai Chi group, the exercise content is totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to the 15 minutes of relaxation exercise. Each session also lasted for about 1 hour and 20 minutes. The 5 forms of Suen Style of Tai Chi are chosen because it will encourage larger limbs movement as well as chest wall movement incorporated with diaphragmatic breathing and breathing control.
Details of the 5 forms of Sun Style Tai Chi chosen are:
The exercise intensity level of the aerobic activities will be set at a target heart rate of 60-70 % of their maximum heart rate and rate of perceived dyspnea(RPD) level of not more than 7. Vital signs will be monitored before, during & after exercise to ensure that the exercise heart rate does not exceed the target level. Also, any time when patient feels discomfort with RPD level reaching 7, the exercise will be stopped and patient is allowed to rest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai chi + PRP | Experimental | 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. |
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| PRP | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai chi + PRP | Other | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Self Efficacy :COPD Self Efficacy Scale (CSES) | 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 | Change in CSES at 6 months post-intervention |
| Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB) | 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. | Change in SEMSOB at 6 months post-intervention |
| SGRQ HKC-Symptoms | 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. | 6 months post-intervention |
| SGRQ HKC-Activity | 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. | 6 months post-intervention |
| SGRQ HKC-Impact | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 MWT in Meters | 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. | 6 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| lorna Ng, doctor | Kwong Wah Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwong Wah Hospital General Out-patient Clinic | Hong Kong SAR | China |
Using the inclusion and exclusion criteria, 192 adult subjects were enrolled into the study
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| PRP | Other | 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 |
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| 6 months post-intervention |
| SGRQ HKC Total | 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. | 6 months post-intervention |
| FVC | Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry | 6 months post intervention |
| FEV1 | Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry | 6 months post-intervention |
| FEV1% Pred | Pred FEV1 percent predicted normal values;measured using spirometry | 6 months post-intervention |
| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| COPD-CSES | 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) | Mean | Standard Deviation | rating score 0.2 to 1 |
| ||||||||||||||
| SEMSOB | 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. | Mean | Standard Deviation | likert scale |
| ||||||||||||||
| SGRQ HKC Symptom | 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. | Mean | Standard Deviation | score from 0 to 100 |
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| SGRQ HK-Activity | 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. | Mean | Standard Deviation | score from 0 to 100 |
| ||||||||||||||
| SGRQ HKC-Impact | 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. | Mean | Standard Deviation | score from 0 to 100 |
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| SGRQ-HKC Total | 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. | Mean | Standard Deviation | score from 0 to 100 |
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| 6 MWT | 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. | Mean | Standard Deviation | Distance in meters |
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| FVC | Forced vital capacity is a component of lung function parameters measured using spirometry | Mean | Standard Deviation | liters |
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| FEV1 | Forced expiratory volume in one second ; component of lung function parameters measured by spirometry | Mean | Standard Deviation | liters |
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| FEV1% Pred | Pred FEV1 percent predicted normal values ; component of lung function parameters measured by spirometry | Mean | Standard Deviation | percentage of predicted normal values |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self Efficacy :COPD Self Efficacy Scale (CSES) | 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 | Intention to treat was used in the analysis | Posted | Mean | Standard Deviation | rating score of 0.2 to 1 | Change in CSES at 6 months post-intervention |
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| Primary | Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB) | 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. | Intention to treat | Posted | Mean | Standard Deviation | units on a scale | Change in SEMSOB at 6 months post-intervention |
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| Primary | SGRQ HKC-Symptoms | 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. | Intention to treat analysis | Posted | Mean | Standard Deviation | units on a scale | 6 months post-intervention |
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| Primary | SGRQ HKC-Activity | 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. | Intention to treat analysis | Posted | Mean | Standard Deviation | units on a scale | 6 months post-intervention |
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| Primary | SGRQ HKC-Impact | 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. | intention to treat | Posted | Mean | Standard Deviation | units on a scale | 6 months post-intervention |
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| Primary | SGRQ HKC Total | 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. | Intention to treat analysis | Posted | Mean | Standard Deviation | units on a scale | 6 months post-intervention |
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| Secondary | 6 MWT in Meters | 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. | Intention to treat analysis | Posted | Mean | Standard Deviation | meters | 6 months post-intervention |
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| Secondary | FVC | Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry | Intention to treat analysis | Posted | Mean | Standard Deviation | liters | 6 months post intervention |
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| Secondary | FEV1 | Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry | Intention to treat analysis | Posted | Mean | Standard Deviation | liters | 6 months post-intervention |
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| Secondary | FEV1% Pred | Pred FEV1 percent predicted normal values;measured using spirometry | Intention to treat | Posted | Mean | Standard Deviation | percentage of FEV1 predicted | 6 months post-intervention |
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Both PRP and PRP+Tai chi were followed up to 6 months post-intervention.
"serious" and "other " adverse events were not assessed and collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRP + Tai Chi | Tai Chi elements added to PRP program | 0 | 0 | 0 | 0 | ||
| EG001 | Pulmonary Rehabilitation Program PRP | Subjects who received formal pulmonary rehabilitation program | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lorna Ng | Kwong Wah Hospital | (852) 23322311 | ngl@ha.org.hk |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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