COPDNCT04357678
Qui Gong Programme vs Short Form Sun Style Tai Chi in COPD Patients
A study testing Qi Gong Programme and Short Form Sun Style Tai Chi in people with COPD, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- Qi Gong Programme and Short Form Sun Style Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Qui Gong Programme With Short Form Sun Style Tai Chi in COPD Patients
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.
Read the detailed 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.
- Conditions
- COPD
- Being tested
- Qi Gong Programme, Short Form Sun Style Tai Chi
- Keywords
- Pulmonary Disease, Qigong, Tai chi
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qi Gong ProgrammeOther
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 ChiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Qi Gong Programme | Experimental | Qi Gong Programme Receives: Other: Qi Gong Programme |
| Short Form Sun Style Tai Chi | Experimental | Short Form Sun Style Tai Chi Receives: Other: Short Form Sun Style Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6th week
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
Secondary outcomes (2)
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"
Measured: 6 week
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Aug 2019
- Primary completion30 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MsCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357678
- Sponsor's protocol ID
- REC/00590 Qurrat ul Ain
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24280465Chan 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.
PubMed 20229333Wu 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.
PubMed 29713157Zhu 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.
PubMed 30012390Lorna 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
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.
PubMed 22878879Regina Wai Man Leung*, Zoe J. McKeough, Matthew J. Peters
Kantatong T, Panpanich R, Deesomchok A, Sungkarat S, Siviroj P. Effects of the tai chi qigong programme on functional capacity, and lung function in chronic obstructive pulmonary disease patients: A ramdomised controlled trial. J Tradit Complement Med. 2019 Apr 1;10(4):354-359. doi: 10.1016/j.jtcme.2019.03.008. eCollection 2020 Jul.
PubMed 32695652Vestbo J, Hurd SS, Agusti 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.
PubMed 22878278
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Qui Gong Programme With Short Form Sun Style Tai Chi in COPD Patients
- ClinicalTrials.gov ID
- NCT04357678
- Acronym / sponsor ID
- REC/00590 Qurrat ul Ain
- Conditions
- COPD
- Keywords
- Pulmonary Disease, Qigong, Tai chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qi Gong Programme | Experimental | Other: Qi Gong ProgrammeQi Gong Programme |
| Short Form Sun Style Tai Chi | Experimental | Other: Short Form Sun Style Tai ChiShort Form Sun Style Tai Chi |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qi Gong ProgrammeWarm-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. | Other | Qi Gong Programme |
| Short Form Sun Style Tai ChiCommencing 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. | Other | Short Form Sun Style Tai Chi |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 6th week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 6th week
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Peak Expiratory Flow (PEF)
Time frame: 6th week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
6 min walk test: Distance (meters)
Time frame: 6th week
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.
2 secondary outcomes
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: 6 week
Quality of life: St. George's Respiratory Questionnaire (SGRQ)
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Background: PubMed 24280465Chan 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.
- Background: PubMed 20229333Chan 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.
- Background: PubMed 29713157Wu 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.
- Background: PubMed 30012390Zhu 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.
- BackgroundLorna 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.
- BackgroundNagaratnam N. NK, Cheuk G. Chronic Obstructive Pulmonary Disease (COPD). Geriatric Diseases 2018
- Background: PubMed 22878879Leung 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.
- BackgroundRegina Wai Man Leung*, Zoe J. McKeough, Matthew J. Peters
- Background: PubMed 32695652Kantatong T, Panpanich R, Deesomchok A, Sungkarat S, Siviroj P. Effects of the tai chi qigong programme on functional capacity, and lung function in chronic obstructive pulmonary disease patients: A ramdomised controlled trial. J Tradit Complement Med. 2019 Apr 1;10(4):354-359. doi: 10.1016/j.jtcme.2019.03.008. eCollection 2020 Jul.
- Background: PubMed 22878278Vestbo J, Hurd SS, Agusti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqbal Tariq, MsCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qi Gong Programme and Short Form Sun Style Tai Chi in people with COPD, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 5 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 22 Apr 2020. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357678, which also lists 10 linked publications.
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 22 Apr 2020.