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

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD  

Official title:

Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259245
• Other study ID #: HHSRF08091291
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: March 2, 2013
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Kwong Wah Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. Medical aspect: GOLD staging of COPD; Baseline spirometry test including bronchodilator reversibility test.

2. Self-Efficacy: COPD Self Efficacy Scale (CSES); Self-Efficacy for Managing Shortness of Breath (SEMSOB)

3. Quality of life related measures: St. George Respiratory Questionnaire ( SGRQ)

4. Exercise Capacity: 6 Minutes Walking Distance Test (6MWT)

Reassessment done at 2 months and 6 months using:

1. Primary Outcome measures and Secondary measures outcome mentioned in outcome measures

2. Spirometry exclusive of bronchodilator reversibility test

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:

1. commencing form

2. single whip : left and right

3. turn with slanted flying: left and right

4. wave hands like clouds: left and right

5. moving as if shutting a door

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• 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

Locations

Country	Name	City	State
China	Kwong Wah Hospital General Out-patient Clinic	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Kwong Wah Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Change in CSES at 6 months post-intervention	No
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.	Change in SEMSOB at 6 months post-intervention	No
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.	6 months post-intervention	No
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.	6 months post-intervention	No
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.	6 months post-intervention	No
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.	6 months post-intervention	No
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.	6 months post-intervention	No
Secondary	FVC	Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry	6 months post intervention	No
Secondary	FEV1	Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry	6 months post-intervention	No
Secondary	FEV1% Pred	Pred FEV1 percent predicted normal values;measured using spirometry	6 months post-intervention	No