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Chronic Obstructive Pulmonary DiseaseCOPDNCT01259245

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

A study testing Tai chi + PRP and PRP in people with Chronic Obstructive Pulmonary Disease, run by Kwong Wah Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Tai chi + PRP and PRP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteChina
Study dates
Mar 2011to May 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • . Previous diagnosis of COPD
  • . Absence of bronchiectasis, bronchiolitis obliterans, panbronchiolitis and asthma
  • . Medical Research Council(MRC)Dyspnea score > 2 using the 1-5 scale version
  • .Willing to participate and able to give consent

Who cannot join

  • . Patients with poor mobility, i.e. wheelchair bound; or
  • . Patients with severe comorbidities, including acute myocardial infarction in preceding 6 months; or
  • . Patients with severe hearing impairment or cognitive impairment; or
  • . Patient unwilling to participate and unable to give consent

Trial locations and contacts

1 site in 1 country.

China1 site
  • Kwong Wah Hospital General Out-patient Clinic

    Hong Kong SAR

Other trials in China

About this study

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.

Read the 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.

Being tested
Tai chi + PRP, PRP
Keywords
Chronic obstructive pulmonary disease COPD, pulmonary rehabilitation program PRP, Tai chi
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai chi + PRPOther

    Also called Tai chi elements added to pulmonary rehabilitation program

    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

  • PRPOther

    Also called Formal pulmonary rehabilitation program

    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

Study groups in NCT01259245
Study groupRoleWhat they receive
Tai chi + PRPExperimentalTai 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.
Receives: Other: Tai chi + PRP; Other: PRP
PRPActive comparatorPRP 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.
Receives: Other: PRP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change in CSES at 6 months post-intervention

  2. 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.

    Measured: Change in SEMSOB at 6 months post-intervention

  3. 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.

    Measured: 6 months post-intervention

  4. 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.

    Measured: 6 months post-intervention

  5. 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.

    Measured: 6 months post-intervention

  6. 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.

    Measured: 6 months post-intervention

Secondary outcomes (4)
  1. 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.

    Measured: 6 months post-intervention

  2. FVC

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

    Measured: 6 months post intervention

  3. FEV1

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

    Measured: 6 months post-intervention

  4. FEV1% Pred

    Pred FEV1 percent predicted normal values;measured using spirometry

    Measured: 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionNov 2011
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01259245
Sponsor's protocol ID
HHSRF08091291
Acronym
COPD
Status last verified
Mar 2013
First submitted
3 Dec 2010
Last updated
5 Mar 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Tai chi + PRP and PRP in people with Chronic Obstructive Pulmonary Disease, run by Kwong Wah Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self Efficacy :COPD Self Efficacy Scale (CSES) (time frame: Change in CSES at 6 months post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.

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