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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01259245
Acronym
COPD
Enrollment
192
Registered
2010-12-14
Start date
2011-03-31
Completion date
2012-05-31
Last updated
2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease COPD, pulmonary rehabilitation program PRP, Tai chi

Brief 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.

Detailed 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.

Interventions

OTHERTai 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

OTHERPRP

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

Sponsors

Kwong Wah Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SGRQ HKC Total6 months post-interventionSGRQ 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.
Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)Change in SEMSOB at 6 months post-interventionThe 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.
SGRQ HKC-Symptoms6 months post-interventionSGRQ 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.
SGRQ HKC-Activity6 months post-interventionSGRQ 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.
SGRQ HKC-Impact6 months post-interventionSGRQ 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.
Self Efficacy :COPD Self Efficacy Scale (CSES)Change in CSES at 6 months post-intervention34 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

Secondary

MeasureTime frameDescription
FVC6 months post interventionForced vital capacity, measured in liters, component of lung function parameters measured by spirometry
FEV16 months post-interventionForced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry
FEV1% Pred6 months post-interventionPred FEV1 percent predicted normal values;measured using spirometry
6 MWT in Meters6 months post-interventionThe 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.

Countries

China

Participant flow

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

Participants by arm

ArmCount
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
98
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
94
Total192

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath12
Overall StudyWithdrawal by Subject2724

Baseline characteristics

CharacteristicTotalTai Chi + PRPPulmonary Rehabilitation Program
6 MWT316.22 Distance in meters
STANDARD_DEVIATION 68.14
312.1 Distance in meters
STANDARD_DEVIATION 64.15
320.2 Distance in meters
STANDARD_DEVIATION 71.86
Age Continuous74 years
STANDARD_DEVIATION 6.624
74 years
STANDARD_DEVIATION 6.41
74 years
STANDARD_DEVIATION 6.81
COPD-CSES0.661 rating score 0.2 to 1
STANDARD_DEVIATION 0.16
0.638 rating score 0.2 to 1
STANDARD_DEVIATION 0.152
0.684 rating score 0.2 to 1
STANDARD_DEVIATION 0.165
FEV11.16 liters
STANDARD_DEVIATION 0.46
1.10 liters
STANDARD_DEVIATION 0.45
1.23 liters
STANDARD_DEVIATION 0.45
FEV1% Pred59.82 percentage of predicted normal values
STANDARD_DEVIATION 23.15
56.38 percentage of predicted normal values
STANDARD_DEVIATION 23.81
63.1 percentage of predicted normal values
STANDARD_DEVIATION 22.11
FVC2.15 liters
STANDARD_DEVIATION 0.74
2.05 liters
STANDARD_DEVIATION 0.66
2.26 liters
STANDARD_DEVIATION 0.8
Region of Enrollment
Hong Kong
192 participants94 participants98 participants
SEMSOB6.70 likert scale
STANDARD_DEVIATION 2.171
6.53 likert scale
STANDARD_DEVIATION 1.98
6.86 likert scale
STANDARD_DEVIATION 2.34
Sex: Female, Male
Female
17 Participants6 Participants11 Participants
Sex: Female, Male
Male
175 Participants88 Participants87 Participants
SGRQ HK-Activity46.84 score from 0 to 100
STANDARD_DEVIATION 23.36
50.75 score from 0 to 100
STANDARD_DEVIATION 22.77
43.08 score from 0 to 100
STANDARD_DEVIATION 23.42
SGRQ HKC-Impact25.74 score from 0 to 100
STANDARD_DEVIATION 18.74
27.43 score from 0 to 100
STANDARD_DEVIATION 20.02
24.11 score from 0 to 100
STANDARD_DEVIATION 17.37
SGRQ HKC Symptom28.65 score from 0 to 100
STANDARD_DEVIATION 19.8
29.77 score from 0 to 100
STANDARD_DEVIATION 19.94
27.57 score from 0 to 100
STANDARD_DEVIATION 19.71
SGRQ-HKC Total32.61 score from 0 to 100
STANDARD_DEVIATION 17.87
34.89 score from 0 to 100
STANDARD_DEVIATION 18.39
30.44 score from 0 to 100
STANDARD_DEVIATION 17.16

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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

Time frame: Change in CSES at 6 months post-intervention

Population: Intention to treat was used in the analysis

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramSelf Efficacy :COPD Self Efficacy Scale (CSES)0.733 rating score of 0.2 to 1Standard Deviation 0.143
Tai Chi + PRPSelf Efficacy :COPD Self Efficacy Scale (CSES)0.685 rating score of 0.2 to 1Standard Deviation 0.137
p-value: 0.25295% CI: [-0.046, 0.012]ANCOVA
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.

Time frame: Change in SEMSOB at 6 months post-intervention

Population: Intention to treat

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramSelf- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)7.13 units on a scaleStandard Deviation 1.98
Tai Chi + PRPSelf- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)7.03 units on a scaleStandard Deviation 1.75
Comparison: power0.80 for a medium effect size at 5% level of significancep-value: 0.98495% CI: [-0.438, 0.447]ANCOVA
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.

Time frame: 6 months post-intervention

Population: Intention to treat analysis

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramSGRQ HKC-Activity41.04 units on a scaleStandard Deviation 21.84
Tai Chi + PRPSGRQ HKC-Activity44.92 units on a scaleStandard Deviation 21.89
Comparison: power of 0.80 for medium size effect at 5% level of significancep-value: 0.58895% CI: [-6.001, 3.411]ANCOVA
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.

Time frame: 6 months post-intervention

Population: intention to treat

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramSGRQ HKC-Impact19.56 units on a scaleStandard Deviation 19.36
Tai Chi + PRPSGRQ HKC-Impact20.23 units on a scaleStandard Deviation 19.27
Comparison: power of 0.80 for medium effect size at 5% level of significancep-value: 0.34595% CI: [-6.627, 2.327]ANCOVA
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.

Time frame: 6 months post-intervention

Population: Intention to treat analysis

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramSGRQ HKC-Symptoms23.49 units on a scaleStandard Deviation 19.53
Tai Chi + PRPSGRQ HKC-Symptoms25.58 units on a scaleStandard Deviation 20.06
Comparison: power of 0.80 for a medium effect size at 5% level of significancep-value: 0.86995% CI: [-4.061, 4.805]ANCOVA
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.

Time frame: 6 months post-intervention

Population: Intention to treat analysis

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramSGRQ HKC Total26.72 units on a scaleStandard Deviation 18.39
Tai Chi + PRPSGRQ HKC Total28.60 units on a scaleStandard Deviation 18.33
Comparison: power of 0.80 for medium effect size at 5% level of significancep-value: 0.41395% CI: [-5.753, 2.372]ANCOVA
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.

Time frame: 6 months post-intervention

Population: Intention to treat analysis

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation Program6 MWT in Meters335.1 metersStandard Deviation 68.49
Tai Chi + PRP6 MWT in Meters340.2 metersStandard Deviation 74.2
Comparison: power of 0.80 for medium effect size at 5% level of significancep-value: 0.00495% CI: [4.159, 21.939]ANCOVA
Secondary

FEV1

Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry

Time frame: 6 months post-intervention

Population: Intention to treat analysis

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramFEV11.28 litersStandard Deviation 0.51
Tai Chi + PRPFEV11.21 litersStandard Deviation 0.52
Comparison: power of 0.80 for medium effect size at 5% level of significancep-value: 0.42595% CI: [-0.054, 0.128]ANCOVA
Secondary

FEV1% Pred

Pred FEV1 percent predicted normal values;measured using spirometry

Time frame: 6 months post-intervention

Population: Intention to treat

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramFEV1% Pred66.2 percentage of FEV1 predictedStandard Deviation 24.75
Tai Chi + PRPFEV1% Pred62.52 percentage of FEV1 predictedStandard Deviation 27.65
Comparison: power of 0.80 for medium effect size at 5% level of significancep-value: 0.52895% CI: [-3.5, 6.8]ANCOVA
Secondary

FVC

Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry

Time frame: 6 months post intervention

Population: Intention to treat analysis

ArmMeasureValue (MEAN)Dispersion
Pulmonary Rehabilitation ProgramFVC2.26 litersStandard Deviation 0.77
Tai Chi + PRPFVC2.18 litersStandard Deviation 0.75
Comparison: power of 0.80 for medium effect size at 5% level of significancep-value: 0.5695% CI: [-0.1, 0.184]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026