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

August 14, 2019 updated by: Duangjun Phantayuth, Mahidol University
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
12 weeks
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)
12 weeks
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)
12 weeks
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)
12 weeks.
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)
12 weeks
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)
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline Dyspnea score assessed with visual analog scale at 12 weeks
Time Frame: 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.
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Amornpan Ajjimaporn, Ph.D, Mahidol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MU-CIRB 2015/133.2808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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