Clinical trial NCT02770677: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Yoga
COPD
rehabilitation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Detail of intervention is Yoga training program. 3 times /week ,12 weeks .
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline FVC (Forced Vital Capacity) (L) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline FEV1 (Forced Expiratory Volume in 1 minute)(L) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline TLC (Total Lung Capacity) (L) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline FRC (Functional Residual Capacity) (L) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline IC (Inspiratoy Capacity) (L) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline RV (Residual Volume) (L) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline MVV (Maximum Voluntary Ventilation) (L/min) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline PEFR (Peak Expiratory Flow Rate) (L/sec) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline DLCO (Diffusion capacity to carbon monoxide) (ml/mmHg/min) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline PI max (Maximal Inspiratoy Pressure) (cm H2O) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline PE max (Maximal Expiratoy Pressure) (cm H2O) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline FEV1/FVC % predicted at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline lower body strength assessed with Chair Standing test at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline upper body strength assessed with Arm curl test at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline lower body flexibility assessed with Chair Sit and Reach test at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline upper body flexibility assessed with Back Scratch test at 12 weeks
timeFrame: 12 weeks.
measure: Change from baseline agility/dynamic balance assessed with 8-foot Up and Go test at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline Exercise Capacity assessed with 6-minute walk test at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline Dyspnea score assessed with visual analog scale at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline Quality of life score assessed with St. George's respiratory Questionnaires (SGRQ) at 12 weeks.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol
name: Amornpan Ajjimaporn, Ph.D
role: STUDY_CHAIR
References: