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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02770677
• Other study ID #: MU-CIRB 2015/133.2808
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2016
• Est. completion date: October 30, 2019

Study information

• Verified date: August 2019
• Source: Mahidol University
• Contact: Duangjun Phantayuth, M.Sc.
• Phone: 6624414295
• Email: leksalaya[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Stable COPD patients > or equal 6 weeks.

2. Age > or equal 50-80 years.

3. FEV1 > or equal 30% predicted after take bronchodilators drug.

4. Resting SpO2 > or equal 90% room air.

5. Did not pulmonary rehabilitation program before start the yoga

Exclusion Criteria:

1. Subjects with musculoskeletal disorders, mental and neurological disorders, and acute coronary heart disease.

2. Blood Pressure (systolic) > 180 mmHg.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Modified Dantien Salee Yoga Training Program
The intervention aims to improve pulmonary function and functional fitness.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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
Primary	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	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
Secondary	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