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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Exercise capacity 6 minute walk distance (6MWD) in meter.
研究概览
简要总结
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.
详细描述
Hypotheses : The Investigator hypothesized that Yoga exercises improve the lung function (i.e. decrease in the lung hyperinflation, air trapping and airway impedance) by stretching the lung tissue, strengthening the respiratory muscles and increasing the chest expansion. Yoga exercises help to increase exercise capacity. Meditation reduces anxiety and depression.
Research Question: Do yoga exercises and meditation help to reduce respiratory impedance, hyperinflation, air trapping and increase exercise capacity and improve quality of life in COPD patients compared to control arm?
Objectives: 1. To study the effect of yoga exercises and meditation on exercise capacity and quality of life in COPD patients after 4, 8 and 12-weeks of intervention.
2.To evaluate residual volume (RV), residual volume/ total lung volume RV/TLC, total lung capacity TLC,inspiratory capacity/total lung capacity IC/TLC, and respiratory impedance in COPD patients after 4, 8 and 12-weeks of yoga exercises and meditation practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who is willing to provide written informed consent.
- •Male or female COPD patients aged ≥30 and < 70 years.
- •Subjects who are willing to do yoga exercises.
- •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.
排除标准
- •Active smoker.
- •Pregnant women or nursing mothers. (Urine pregnancy test will be performed.)
- •Those unable to perform spirometry and body plethysmography.
- •Participants having symptoms of active pulmonary Koch's (tuberculosis).
- •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.
- •Contraindications for Body Plethysmography: Subject having any of the following contraindications for body plethysmography
- •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).
- •History of Claustrophobia.
- •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).
- •Anyone who is on continuous oxygen therapy
- •Patients who are doing yoga or taking pulmonary rehabilitation from last 6 months.
- •History of thoracic cage abnormality, musculoskeletal abnormality, interstitial lung disease, epilepsy
- •Patients who are unable to perform yoga exercises.
- •Contraindications for 6 Minute walk test:
- •Absolute Contraindications: Unstable angina during the previous month and myocardial infarction during the previous month.
- •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.
研究组 & 干预措施
Effect of yoga exercises in COPD patients after 12 weeks.
Yoga group
干预措施: Yoga breathing exercises and Meditation (Other)
COPD patients lung functions without yoga excercises.
Control group
结局指标
主要结局
Exercise capacity 6 minute walk distance (6MWD) in meter.
时间窗: 3 Months.
Effect of Yoga Exercises and Meditation on 6 minute walk distance (6 MWD) after 12 week in COPD patients.
St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers.
时间窗: 3 Months
Effect of Yoga Exercises and Meditation on SGRQ score after 12 week in COPD patients.
次要结局
- RV/TLC in%(3 Months)
- TLC in liters(3 Months)
- Respiratory impedance in kpa/(L/s)(3 Months)
研究者
Dr.Sundeep S Salvi
Director
Chest Research Foundation, India