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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04357678
Other study ID # REC/00590 Qurrat ul Ain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date January 10, 2020

Study information

Verified date April 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a Randomized control Trial. Purposive sampling was done to obtained Sample (n=78) which were randomly allocated to Group A (n=39) and Group B (n=39). Study was conducted from August 2019 to December 2019 in HBS Hospital Islamabad.To determine the effects of Qigong vs. Shot form Sun Style Tai Chi (SSTC) on Lung function, six min walk distance, dyspnea and quality of life in COPD patients.


Description:

Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and air-flow limitation. Dyspnea is related with daily life activity. COPD patients often suffer from dyspnea and exacerbation, which leads to inactivity, deconditioning, and poor functional capacity and quality of life. Several interventions have been investigated with the aim of improving lung function, decreasing dyspnea symptoms and improving quality of life in this patient.

Tai Chi, an exercise involving both upper and lower extremities, originated from China. Tai chi is characterized by posture alignment, weight shifting and circular movements that incorporate elements of muscle endurance and strengthening, balance, relaxation and breathing control. Among previous studies Tai Chi in pulmonary rehabilitation showed a modest complementary benefit in exercise capacity.

The Tai Chi program is a safe, effective and feasible method to improve exercise capacity and health-related quality of life in people with COPD. Short form sun style Tai chi is one of the most common styles of t'ai chi. each form can be broken down into several movements which make it easy to learn and teach. Compared to some other styles of t'ai chi, SSTC involves less difficult movements, such as less deep-knee bending and single leg standing, which may make it more suitable for older people.

Qi Gong is defined as a mind-body exercise that involves whole body movements, breathing techniques, postural control, and internal awareness.

effects of Qi Gong on functional capacity and lung functions in COPD patients , and concluded that functional capacity, dyspnea scores and quality of life was significantly improved in mild to moderate COPD patients.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date January 10, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Clinically Diagnosed patient: Mild to moderate stage COPD according to GOLD criteria {i-e Global Initiative for Chronic Obstructive Lung Disease (GOLD) }

- Patients who can walk without any dependency were included in study.

Exclusion Criteria:

- Patients with acute exacerbation within 4 weeks before starting the study

- Patient having significant, cognitive impairment

- Patient having Tuberculosis, asthma

- Patient having musculoskeletal

- Patient having psychological, cardiovascular and benign conditions (that prohibit exercise were excluded from the study)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Qi Gong Programme
Warm-up: In warm up session joint activities were performed along with light stretching. Patients performed these activities with instructor's commands for 5 minutes. Liu Zi Jue exercise: patients performed intact Liu Zi Jue exercise (form of Qigong). This includes six healing sounds, Xu, He, Hu, Si, Chui, Xi and the Harmonized actions along with the instructor for 20 minutes. Cooling-down: After completion of Qigong, patient done gentle stretching to adjust back their breathing and this cool down session lasted for 5 minutes. Subjects received supervised training session for 30 min twice a week.
Short Form Sun Style Tai Chi
Commencing Movement, Opening and closing hand, Single whip, Waving hands in the cloud, Opening and closing hands, Brush knee, Playing lute, Perry and Punch, Block and close, Pushing the mountain, Closing movement. Participants attended two supervised 30min sessions twice a week. Participants learnt 3 to 4 forms per week and at the completion of study (which is the six week of training), they completed all 21 forms. In each training session, participants revised previous SSTC forms that they learnt earlier up to that session.

Locations

Country Name City State
Pakistan HBS General Hospital Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Chan AW, Lee A, Lee DT, Suen LK, Tam WW, Chair SY, Griffiths P. The sustaining effects of Tai chi Qigong on physiological health for COPD patients: a randomized controlled trial. Complement Ther Med. 2013 Dec;21(6):585-94. doi: 10.1016/j.ctim.2013.09.008. Epub 2013 Oct 8. — View Citation

Chan AW, Lee A, Suen LK, Tam WW. Effectiveness of a Tai chi Qigong program in promoting health-related quality of life and perceived social support in chronic obstructive pulmonary disease clients. Qual Life Res. 2010 Jun;19(5):653-64. doi: 10.1007/s11136-010-9632-6. Epub 2010 Mar 15. Erratum in: Qual Life Res. 2010 Oct;19(8):1241. — View Citation

Leung RW, McKeough ZJ, Peters MJ, Alison JA. Short-form Sun-style t'ai chi as an exercise training modality in people with COPD. Eur Respir J. 2013 May;41(5):1051-7. doi: 10.1183/09031936.00036912. Epub 2012 Aug 9. — View Citation

Lorna Ng LK, Raymond Tang ,Cheetham Siu, Lawrence Fung, Albert Lee, Wilson Tamd. Effectiveness of incorporating Tai Chi in a pulmonary rehabilitation program for Chronic Obstructive Pulmonary Disease (COPD) in primary care—A pilot randomized controlled trial. European Journal of Integrative Medicine2015;6(3): 248-58.

Nagaratnam N. NK, Cheuk G. Chronic Obstructive Pulmonary Disease (COPD). Geriatric Diseases 2018

Tassawan Kantatong RP, Athavudh Deesomchok , Somporn Sungkarat , Penprapa Siviroj Effects of the tai chi qigong programme on functional capacity, and lung function in chronic obstructive pulmonary disease patients: A randomized controlled trial Journal of Traditional and Complementary Medicine 2019

Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review. — View Citation

Wu LL, Lin ZK, Weng HD, Qi QF, Lu J, Liu KX. Effectiveness of meditative movement on COPD: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 Apr 17;13:1239-1250. doi: 10.2147/COPD.S159042. eCollection 2018. Review. — View Citation

Zhu S, Shi K, Yan J, He Z, Wang Y, Yi Q, Huang H. A modified 6-form Tai Chi for patients with COPD. Complement Ther Med. 2018 Aug;39:36-42. doi: 10.1016/j.ctim.2018.05.007. Epub 2018 May 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Forced Expiratory Volume in 1 second (FEV1) Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters 6th week
Primary Forced vital Capacity (FVC) Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters. 6th week
Primary Peak Expiratory Flow (PEF) Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second. 6th week
Primary 6 min walk test: Distance (meters) Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support. 6th week
Secondary Modified Medical Research Council Dyspnea Scale (mMRC) Changes from the Baseline, It was used to measure Dyspnea score. This scale ranges from 0 to 4 in which 0 indicates that strenuous exercise leads to breathlessness" and 4 means "too breathless" 6 week
Secondary Quality of life: St. George's Respiratory Questionnaire (SGRQ) was used to access the quality of life; SGRQ is used for determining quality of life in COPD patients. This questionnaire is designed in 50 items to check the impact of COPD. 0 to 100 is the range of this score. Scores having higher values means more limitations. 6 week
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