COPD Clinical Trial
Official title:
A Pilot Study to Evaluate the Effect of Yoga Exercises and Meditation on Lung Volume, Respiratory Impedance, 6-minute Walk Distance and Quality of Life in Chronic Obstructive Pulmonary Disease(COPD) Patients.
NCT number | NCT04020081 |
Other study ID # | CRF/01/2017 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2018 |
Est. completion date | January 2020 |
The Investigator would like to study the effect of yoga exercises and meditation on lung volume, respiratory impedance, 6-minute walk distance and quality of life in COPD patients.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2020 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Subject who is willing to provide written informed consent. 2. Male or female COPD patients aged =30 and < 70 years. 3. Subjects who are willing to do yoga exercises. 4. Clinical diagnosis of COPD confirmed on spirometry. Pre and post bronchodilator ratio of forced expiratory volume in 1sec/ forced vital capacity (FEV1/FVC) should be less than 0.7. Exclusion Criteria: 1. Active smoker. 2. Pregnant women or nursing mothers. (Urine pregnancy test will be performed.) 3. Those unable to perform spirometry and body plethysmography. 4. Participants having symptoms of active pulmonary Koch's (tuberculosis). 5. Contraindications for spirometry: Subject having any of the following contraindications for spirometry. History of the following a) Recent (within 1 month) myocardial infarction. b) Unstable heart condition c) Hemoptysis (blood in sputum on coughing) in recent past (1 month) or d) A recent (within last one month) eye, chest or abdominal surgery. 6. Contraindications for Body Plethysmography: Subject having any of the following contraindications for body plethysmography 1. Mental confusion, muscular in coordination, body casts, or other conditions that prevent the subject from entering the plethysmograph cabinet or adequately performing the required maneuvers (i.e., panting against a closed shutter). 2. History of Claustrophobia. 3. Presence of devices or other conditions, such as continuous intravenous infusions with pumps or other equipment that will not fit into the plethysmograph, that should not be discontinued, or that might interfere with pressure changes (e.g., chest tube, trans tracheal O2 catheter, or ruptured eardrum). 7. Anyone who is on continuous oxygen therapy 8. Patients who are doing yoga or taking pulmonary rehabilitation from last 6 months. 9. History of thoracic cage abnormality, musculoskeletal abnormality, interstitial lung disease, epilepsy 10. Patients who are unable to perform yoga exercises. 11. Contraindications for 6 Minute walk test: 1. Absolute Contraindications: Unstable angina during the previous month and myocardial infarction during the previous month. 2. Relative Contraindications : Resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg. |
Country | Name | City | State |
---|---|---|---|
India | Chest Research Foundation | Pune | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Chest Research Foundation, India | Jupiter Hospital, India |
India,
Donesky-Cuenco D, Nguyen HQ, Paul S, Carrieri-Kohlman V. Yoga therapy decreases dyspnea-related distress and improves functional performance in people with chronic obstructive pulmonary disease: a pilot study. J Altern Complement Med. 2009 Mar;15(3):225-34. doi: 10.1089/acm.2008.0389. — View Citation
Kaminsky DA, Guntupalli KK, Lippmann J, Burns SM, Brock MA, Skelly J, DeSarno M, Pecott-Grimm H, Mohsin A, LaRock-McMahon C, Warren P, Whitney MC, Hanania NA. Effect of Yoga Breathing (Pranayama) on Exercise Tolerance in Patients with Chronic Obstructive Pulmonary Disease: A Randomized, Controlled Trial. J Altern Complement Med. 2017 Sep;23(9):696-704. doi: 10.1089/acm.2017.0102. Epub 2017 Jul 17. — View Citation
Liu XC, Pan L, Hu Q, Dong WP, Yan JH, Dong L. Effects of yoga training in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Thorac Dis. 2014 Jun;6(6):795-802. doi: 10.3978/j.issn.2072-1439.2014.06.05. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers. | Effect of Yoga Exercises and Meditation on SGRQ score after 12 week in COPD patients. | 3 Months | |
Primary | Exercise capacity 6 minute walk distance (6MWD) in meter. | Effect of Yoga Exercises and Meditation on 6 minute walk distance (6 MWD) after 12 week in COPD patients. | 3 Months. | |
Secondary | RV/TLC in% | Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients. | 3 Months | |
Secondary | TLC in liters | Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients. | 3 Months | |
Secondary | Respiratory impedance in kpa/(L/s) | Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients. | 3 Months |
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