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临床试验/CTRI/2019/04/018357
CTRI/2019/04/018357尚未招募不适用

Pulmonary rehabilitation in post tubercular obstructive airway disease

DEPARTMENT OF PULMONARY MEDICINE1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
Change in 6MWT

研究概览

简要总结

RESEARCHQUESTION

Does pulmonary rehabilitation improvethe outcome in post TB OAD,as compared to pharmacotherapy alone?

OBJECTIVE

To know the outcome of pulmonary function inpost TB OAD patients after pulmonary rehabilitation.

Subjects  will undergo pulmonary rehabilitation programtwice weekly for 6 weeks, which will include endurance training of upper &lower limb, strength training of upper

and lower limb, stretching exercise andflexibility exercise & will be overseen by physiotherapist in collaborationwith a counselor. they will also continue

pharmacotherapy.Controls will be givenpharmacotherapy alone. After 6 weeks cases will beencouraged to do exercise at home. That will include endurance training

upper& lower limb, stretching exercise & flexibility exercise along withpharmacotherapy.

—  Change  will be seen in the form of 6MWT,mMRC,standardized questionnaire and will be compared with controls.

—  Controls will be called in weekly toexplain importance of medication and to check if the technique of takingmedication is correct or not.

Enrollment will be up to 1 year.

All patient’s will be followed upfor  6 month in 3 monthly interval tocollect data through structured questionnaire.

Enrolled patients will be reminded aboutscheduled follow up date by telephone.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.MORE THAN 18 YEARS 2.Subjects diagnosed with post TB OAD.
  • 3.Willing to come to pulmonary rehabilitation centre at pulmonary medicine department twice a week for 4 weeks.

排除标准

  • 1.ACTIVE TB(MICROBIOLOGICALY CONFIRMED) 2.NON TUBERCULAR COPD 3.AGE<18YRS 4PATIENT IN ACUTE EXACERBATION 5.UNSTABLE CARDIOVASCULAR DISEASE.

结局指标

主要结局

Change in 6MWT

时间窗: 6 months.

Change in mMRC dyspnea scale

时间窗: 6 months.

Change in frequency of exacerbation

时间窗: 6 months.

Change in quality of life

时间窗: 6 months.

Change in frequency of hospitalization

时间窗: 6 months.

Change in FEV1

时间窗: 6 months.

次要结局

  • improvement in quality of life(1 year)

研究者

发起方
DEPARTMENT OF PULMONARY MEDICINE
申办方类型
Government medical college

研究点 (1)

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