Back to resultsModified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Modified Dantien Salee Yoga Training Program
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Yoga, COPD, rehabilitation
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.
Sites / Locations
- Faculty of Medicine, Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Yoga group
Arm Description
Control group will be asked to continue their normal daily life without Yoga training
Yoga group will be exposed to Modified Dantien Salee Yoga Training Program for 12 weeks
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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)
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02770677
Brief Title
Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation
Official Title
Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 7, 2016 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Yoga, COPD, rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Detail of intervention is Yoga training program. 3 times /week ,12 weeks .
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will be asked to continue their normal daily life without Yoga training
Arm Title
Yoga group
Arm Type
Experimental
Arm Description
Yoga group will be exposed to Modified Dantien Salee Yoga Training Program for 12 weeks
Intervention Type
Other
Intervention Name(s)
Modified Dantien Salee Yoga Training Program
Intervention Description
The intervention aims to improve pulmonary function and functional fitness.
Primary Outcome Measure Information:
Title
Change from baseline FVC (Forced Vital Capacity) (L) at 12 weeks
Description
Change of FVC (Forced Vital Capacity) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline FEV1 (Forced Expiratory Volume in 1 minute)(L) at 12 weeks
Description
Change of Forced Expiratory Volume in 1 second will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline TLC (Total Lung Capacity) (L) at 12 weeks
Description
Change of TLC (Total Lung Capacity) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline FRC (Functional Residual Capacity) (L) at 12 weeks
Description
Change of FRC (Functional Residual Capacity) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline IC (Inspiratoy Capacity) (L) at 12 weeks
Description
Change of IC (Inspiratoy Capacity) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline RV (Residual Volume) (L) at 12 weeks
Description
Change of RV (Residual Volume) (L) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline MVV (Maximum Voluntary Ventilation) (L/min) at 12 weeks
Description
Change of MVV (Maximum Voluntary Ventilation) (L/min) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline PEFR (Peak Expiratory Flow Rate) (L/sec) at 12 weeks
Description
Change of MVV (Maximum Voluntary Ventilation) (L/sec) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline DLCO (Diffusion capacity to carbon monoxide) (ml/mmHg/min) at 12 weeks
Description
Change of DLCO (Diffusion capacity to carbon monoxide) (ml/mmHg/min) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline PI max (Maximal Inspiratoy Pressure) (cm H2O) at 12 weeks
Description
Change of PI max (Maximal Inspiratoy Pressure) (cm H2O) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline PE max (Maximal Expiratoy Pressure) (cm H2O) at 12 weeks
Description
Change of PE max (Maximal Expiratoy Pressure) (cm H2O) will be measured on a computerized Spirometer at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline FEV1/FVC % predicted at 12 weeks
Description
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.
Time Frame
12 weeks
Title
Change from baseline lower body strength assessed with Chair Standing test at 12 weeks
Description
Change from baseline lower body strength assessed with Chair standing test. ( time/30 sec)
Time Frame
12 weeks
Title
Change from baseline upper body strength assessed with Arm curl test at 12 weeks
Description
Change from baseline upper body strength assessed with Arm curl test (time/30 sec)
Time Frame
12 weeks
Title
Change from baseline lower body flexibility assessed with Chair Sit and Reach test at 12 weeks
Description
Change from baseline lower body flexibility assessed with Chair Sit and Reach test (cm)
Time Frame
12 weeks
Title
Change from baseline upper body flexibility assessed with Back Scratch test at 12 weeks
Description
Change from baseline upper body flexibility assessed with Back Scratch test (cm)
Time Frame
12 weeks.
Title
Change from baseline agility/dynamic balance assessed with 8-foot Up and Go test at 12 weeks
Description
Change from baseline agility/dynamic balance assessed with 8-foot Up and Go test (sec)
Time Frame
12 weeks
Title
Change from baseline Exercise Capacity assessed with 6-minute walk test at 12 weeks
Description
Change from baseline Exercise Capacity assessed with 6-minute walk test (meter)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Dyspnea score assessed with visual analog scale at 12 weeks
Description
Dyspnea or shortness of breath will be measured by visual analog scale (VAS) 1-10 point scale at the baseline and 12 weeks.
Time Frame
12 weeks
Title
Change from baseline Quality of life score assessed with St. George's respiratory Questionnaires (SGRQ) at 12 weeks.
Description
Change from baseline Quality of Life score assessed with St. George's respiratory Questionnaires (SGRQ) in Thai version at 12 weeks.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duangjun Phantayuth, M.Sc.
Phone
6624414295
Ext
311
Email
leksalaya@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amornpan Ajjimaporn, Ph.D
Organizational Affiliation
Mahidol
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arth Nana, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation
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