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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Modified Dantien Salee Yoga Training Program

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Faculty of Medicine, Siriraj Hospital
      • Contact: Arth Nana, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Study Chair: Amornpan Ajjimaporn, Ph.D, Mahidol

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2016
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Yoga; rehabilitation; COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MU-CIRB 2015/133.2808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO