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临床试验/NCT02770677
NCT02770677Unknown不适用

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

Mahidol University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Change from baseline FEV1 (Forced Expiratory Volume in 1 minute)(L) at 12 weeks

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

干预措施: Modified Dantien Salee Yoga Training Program (Other)

结局指标

主要结局

Change from baseline FEV1 (Forced Expiratory Volume in 1 minute)(L) at 12 weeks

时间窗: 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 PEFR (Peak Expiratory Flow Rate) (L/sec) at 12 weeks

时间窗: 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 IC (Inspiratoy Capacity) (L) at 12 weeks

时间窗: 12 weeks

Change of IC (Inspiratoy 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

时间窗: 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 PE max (Maximal Expiratoy Pressure) (cm H2O) at 12 weeks

时间窗: 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 agility/dynamic balance assessed with 8-foot Up and Go test at 12 weeks

时间窗: 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

时间窗: 12 weeks

Change from baseline Exercise Capacity assessed with 6-minute walk test (meter)

Change from baseline MVV (Maximum Voluntary Ventilation) (L/min) at 12 weeks

时间窗: 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 upper body flexibility assessed with Back Scratch test at 12 weeks

时间窗: 12 weeks.

Change from baseline upper body flexibility assessed with Back Scratch test (cm)

Change from baseline FVC (Forced Vital Capacity) (L) at 12 weeks

时间窗: 12 weeks

Change of FVC (Forced Vital Capacity) will be measured on a computerized Spirometer at the baseline and 12 weeks.

Change from baseline TLC (Total Lung Capacity) (L) at 12 weeks

时间窗: 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 RV (Residual Volume) (L) at 12 weeks

时间窗: 12 weeks

Change of RV (Residual Volume) (L) 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

时间窗: 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

时间窗: 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 FEV1/FVC % predicted at 12 weeks

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 12 weeks

Change from baseline lower body flexibility assessed with Chair Sit and Reach test (cm)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Duangjun Phantayuth

Assistant Professor

Mahidol University

研究点 (2)

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