Pulmonary Disease, Chronic ObstructiveNCT02770677
Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation
A study testing Modified Dantien Salee Yoga Training Program in people with Pulmonary Disease, Chronic Obstructive, run by Mahidol University at 1 site in Thailand.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Modified Dantien Salee Yoga Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteThailand
- Study dates
- 7 Apr 2016to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with musculoskeletal disorders, mental and neurological disorders, and acute coronary heart disease.
- Blood Pressure (systolic) > 180 mmHg.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Arth Nana, MD
About this study
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Modified Dantien Salee Yoga Training Program
- Keywords
- Yoga, COPD, rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Dantien Salee Yoga Training ProgramOther
The intervention aims to improve pulmonary function and functional fitness.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group will be asked to continue their normal daily life without Yoga training |
| Yoga group | Experimental | Yoga group will be exposed to Modified Dantien Salee Yoga Training Program for 12 weeks Receives: Other: Modified Dantien Salee Yoga Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start7 Apr 2016
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Detail of intervention is Yoga training program. 3 times /week ,12 weeks .
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duangjun Phantayuth, Mahidol University
- Investigators
- Amornpan Ajjimaporn, Ph.D, Study chair, Mahidol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770677
- Sponsor's protocol ID
- MU-CIRB 2015/133.2808
- Status last verified
- Aug 2019
- First submitted
- 20 Apr 2016
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation
- ClinicalTrials.gov ID
- NCT02770677
- Acronym / sponsor ID
- MU-CIRB 2015/133.2808
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Yoga, COPD, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Detail of intervention is Yoga training program. 3 times /week ,12 weeks .
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group will be asked to continue their normal daily life without Yoga training |
| Yoga group | Experimental | Other: Modified Dantien Salee Yoga Training ProgramYoga group will be exposed to Modified Dantien Salee Yoga Training Program for 12 weeks |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects with musculoskeletal disorders, mental and neurological disorders, and acute coronary heart disease.
- Blood Pressure (systolic) > 180 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Dantien Salee Yoga Training ProgramThe intervention aims to improve pulmonary function and functional fitness. | Other | Yoga group |
Primary outcome
Change from baseline FVC (Forced Vital Capacity) (L) at 12 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Change from baseline Exercise Capacity assessed with 6-minute walk test (meter)
2 secondary outcomes
Change from baseline Dyspnea score assessed with visual analog scale at 12 weeks
Time frame: 12 weeks
Change from baseline Quality of life score assessed with St. George's respiratory Questionnaires (SGRQ) at 12 weeks.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Disease, Chronic Obstructive
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amornpan Ajjimaporn, Ph.D study chair
Mahidol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Dantien Salee Yoga Training Program in people with Pulmonary Disease, Chronic Obstructive, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duangjun Phantayuth, M.Sc. (6624414295 ext. 311, leksalaya@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline FVC (Forced Vital Capacity) (L) at 12 weeks (time frame: 12 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.