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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tai chi + PRP
PRP
Sponsored by
Kwong Wah Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease COPD, pulmonary rehabilitation program PRP, Tai chi

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kwong Wah Hospital General Out-patient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tai chi + PRP

PRP

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
FVC
Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry
FEV1
Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry
FEV1% Pred
Pred FEV1 percent predicted normal values;measured using spirometry

Full Information

First Posted
December 3, 2010
Last Updated
March 2, 2013
Sponsor
Kwong Wah Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01259245
Brief Title
Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for Chronic Obstructive Pulmonary Disease Patients in Primary Health Care
Acronym
COPD
Official Title
Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kwong Wah Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Medical aspect: GOLD staging of COPD; Baseline spirometry test including bronchodilator reversibility test. Self-Efficacy: COPD Self Efficacy Scale (CSES); Self-Efficacy for Managing Shortness of Breath (SEMSOB) Quality of life related measures: St. George Respiratory Questionnaire ( SGRQ) Exercise Capacity: 6 Minutes Walking Distance Test (6MWT) Reassessment done at 2 months and 6 months using: Primary Outcome measures and Secondary measures outcome mentioned in outcome measures 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: commencing form single whip : left and right turn with slanted flying: left and right wave hands like clouds: left and right 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease COPD, pulmonary rehabilitation program PRP, Tai chi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai chi + PRP
Arm Type
Experimental
Arm Description
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.
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tai chi + PRP
Other Intervention Name(s)
Tai chi elements added to pulmonary rehabilitation program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
PRP
Other Intervention Name(s)
Formal pulmonary rehabilitation program
Intervention Description
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
Primary Outcome Measure Information:
Title
Self Efficacy :COPD Self Efficacy Scale (CSES)
Description
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
Title
Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)
Description
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
Title
SGRQ HKC-Symptoms
Description
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
Title
SGRQ HKC-Activity
Description
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
Title
SGRQ HKC-Impact
Description
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
Title
SGRQ HKC Total
Description
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
Secondary Outcome Measure Information:
Title
6 MWT in Meters
Description
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
Title
FVC
Description
Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry
Time Frame
6 months post intervention
Title
FEV1
Description
Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry
Time Frame
6 months post-intervention
Title
FEV1% Pred
Description
Pred FEV1 percent predicted normal values;measured using spirometry
Time Frame
6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . 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 Exclusion Criteria: . 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lorna Ng, doctor
Organizational Affiliation
Kwong Wah Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwong Wah Hospital General Out-patient Clinic
City
Hong Kong SAR
Country
China

12. IPD Sharing Statement

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

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