NCT02770677

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

3.6 years

First QC Date

April 20, 2016

Last Update Submit

August 14, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

YogaCOPDrehabilitation

Outcome Measures

Primary Outcomes (18)

  • 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 Outcomes (2)

  • Change from baseline Dyspnea score assessed with visual analog scale at 12 weeks

    12 weeks

  • Change from baseline Quality of life score assessed with St. George's respiratory Questionnaires (SGRQ) at 12 weeks.

    12 weeks

Study Arms (2)

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

Other: Modified Dantien Salee Yoga Training Program

Interventions

Modified Dantien Salee Yoga Training ProgramOTHER

The intervention aims to improve pulmonary function and functional fitness.

Yoga group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with musculoskeletal disorders, mental and neurological disorders, and acute coronary heart disease.
  • Blood Pressure (systolic) \> 180 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amornpan Ajjimaporn, Ph.D

    Mahidol

    STUDY CHAIR

Central Study Contacts

Duangjun Phantayuth, M.Sc.

CONTACT

6624414295leksalaya@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Detail of intervention is Yoga training program. 3 times /week ,12 weeks .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 20, 2016

First Posted

May 12, 2016

Study Start

April 7, 2016

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

August 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)