Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care
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:
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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