Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation

Study Overview
=================
Brief Summary
-----------------
COPD patients will be recruited and assigned into one of each group: 1) Control group or 2) Yoga group. In Yoga groups, subjected will be asked to participate in Modified Dantien Yoga training for 12 weeks (3 times/week, 60 min/time). The subjects will be evaluated their pulmonary function, functional fitness performance, dyspnea score, and quality of life at baseline and after 12 wk training.

Official Title
-----------------
Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Other: Modified Dantien Salee Yoga Training Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable COPD patients > or equal 6 weeks. Age > or equal 50-80 years. FEV1 > or equal 30% predicted after take bronchodilators drug. Resting SpO2 > or equal 90% room air. Did not pulmonary rehabilitation program before start the yoga Exclusion Criteria: Subjects with musculoskeletal disorders, mental and neurological disorders, and acute coronary heart disease. Blood Pressure (systolic) > 180 mmHg.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Detail of intervention is Yoga training program. 3 times /week ,12 weeks .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group will be asked to continue their normal daily life without Yoga training | |
| Experimental: Yoga group<br>Yoga group will be exposed to Modified Dantien Salee Yoga Training Program for 12 weeks | Other: Modified Dantien Salee Yoga Training Program<br>* The intervention aims to improve pulmonary function and functional fitness.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline FVC (Forced Vital Capacity) (L) at 12 weeks | Change of FVC (Forced Vital Capacity) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline FEV1 (Forced Expiratory Volume in 1 minute)(L) at 12 weeks | Change of Forced Expiratory Volume in 1 second will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline TLC (Total Lung Capacity) (L) at 12 weeks | Change of TLC (Total Lung Capacity) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline FRC (Functional Residual Capacity) (L) at 12 weeks | Change of FRC (Functional Residual Capacity) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline IC (Inspiratoy Capacity) (L) at 12 weeks | Change of IC (Inspiratoy Capacity) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline RV (Residual Volume) (L) at 12 weeks | Change of RV (Residual Volume) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline MVV (Maximum Voluntary Ventilation) (L/min) at 12 weeks | Change of MVV (Maximum Voluntary Ventilation) (L/min) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline PEFR (Peak Expiratory Flow Rate) (L/sec) at 12 weeks | Change of MVV (Maximum Voluntary Ventilation) (L/sec) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline DLCO (Diffusion capacity to carbon monoxide) (ml/mmHg/min) at 12 weeks | Change of DLCO (Diffusion capacity to carbon monoxide) (ml/mmHg/min) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline PI max (Maximal Inspiratoy Pressure) (cm H2O) at 12 weeks | Change of PI max (Maximal Inspiratoy Pressure) (cm H2O) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline PE max (Maximal Expiratoy Pressure) (cm H2O) at 12 weeks | Change of PE max (Maximal Expiratoy Pressure) (cm H2O) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline FEV1/FVC % predicted at 12 weeks | Change of FEV1/FVC % Predicted (Percent Predicted of ratio of FEV1 and FVC) (% predicted) will be measured on a computerized Spirometer at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline lower body strength assessed with Chair Standing test at 12 weeks | Change from baseline lower body strength assessed with Chair standing test. ( time/30 sec) | 12 weeks | 
| Change from baseline upper body strength assessed with Arm curl test at 12 weeks | Change from baseline upper body strength assessed with Arm curl test (time/30 sec) | 12 weeks | 
| Change from baseline lower body flexibility assessed with Chair Sit and Reach test at 12 weeks | Change from baseline lower body flexibility assessed with Chair Sit and Reach test (cm) | 12 weeks | 
| Change from baseline upper body flexibility assessed with Back Scratch test at 12 weeks | Change from baseline upper body flexibility assessed with Back Scratch test (cm) | 12 weeks. | 
| Change from baseline agility/dynamic balance assessed with 8-foot Up and Go test at 12 weeks | Change from baseline agility/dynamic balance assessed with 8-foot Up and Go test (sec) | 12 weeks | 
| Change from baseline Exercise Capacity assessed with 6-minute walk test at 12 weeks | Change from baseline Exercise Capacity assessed with 6-minute walk test (meter) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Dyspnea score assessed with visual analog scale at 12 weeks | Dyspnea or shortness of breath will be measured by visual analog scale (VAS) 1-10 point scale at the baseline and 12 weeks. | 12 weeks | 
| Change from baseline Quality of life score assessed with St. George's respiratory Questionnaires (SGRQ) at 12 weeks. | Change from baseline Quality of Life score assessed with St. George's respiratory Questionnaires (SGRQ) in Thai version at 12 weeks. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga, COPD, rehabilitation