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

NCT01259245 | Completed Results DMC

• 1 other identifier: HHSRF08091291
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• 6 MWT in Meters

  6 months post-intervention

• FVC

  6 months post intervention

• FEV1

  6 months post-intervention

• FEV1% Pred

  6 months post-intervention

Study Arms (2)

Tai chi + PRP

EXPERIMENTAL

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.

Other: Tai chi + PRP; Other: PRP

PRP

ACTIVE COMPARATOR

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.

Other: PRP

Interventions

Tai chi + PRP OTHER

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

Also known as: Tai chi elements added to pulmonary rehabilitation program

Tai chi + PRP

PRP OTHER

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

Also known as: Formal pulmonary rehabilitation program

PRP; Tai chi + PRP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kwong Wah Hospital: lead

Study Sites (1)

Kwong Wah Hospital General Out-patient Clinic

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

There was high attrition rate of 28% which further contributed to our small sample size with wide 95% confidence interval of several outcome variables results.

Results Point of Contact

• Title: Dr Lorna Ng
• Organization: Kwong Wah Hospital

ngl@ha.org.hk

(852) 23322311

Study Officials

• lorna Ng, doctor

  Kwong Wah Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Officer

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 14, 2010
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: March 5, 2013
• Results First Posted: March 5, 2013

Record last verified: 2013-03

Locations

CN (1)