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临床试验/CTRI/2013/05/003610
CTRI/2013/05/003610尚未招募不适用

Effectiveness of Inspiratory muscle training in patients with mild to severe asthma

Institutional Review Board1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2013年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
76
试验地点
1
主要终点
PI max-Measurement of the maximum static Inspiratory pressure that a subject can generate at the mouth (PImax) is a simple way to gauge inspiratory muscle strength

研究概览

简要总结

Mild to severe asthmatics who satisfy the study criteria will be consented and randomly allocated into 2 groups-the study group (76 patients) who will receive specific inspiratory muscle training(IMT) and the control group (76 patients). Subjects in both groups will be trained with 2 supervised sessions during the first week, followed by one supervised session per week for a period of 6 weeks, with each session consisting of 0.5 h of training. The subjects in study group will receive specific inspiratory muscle training (SIMT) with a threshold inspiratory muscle trainer. The subjects will start breathing at a resistance level equal to 30% of their PI max for 1 week. They will be instructed to use the trainer at home for half an hour, daily. The resistance will be increased incrementally, by 5 to 10% each supervised session. Patients in group B will receive sham training with the threshold inspiratory muscle trainer with no resistance and they will also have weekly supervised session. All patients will receive standard pharmacotherapy prescribed by the Physician.  An informed consent will be obtained from each patient.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Assessments will be made before and immediately after 6 weeks of training. Asthma control will be measured using Asthma Control Test (ACT)and quality of life will be measured using  St. George Respiratory Disease Questionnaire(SGRQ). Patients will maintain an asthma diary for daily symptoms and PEFR will be measured. Lung function test will be performed using a computerized Spirometry and respiratory muscle strength will be assessed by measuring the maximal inspiratory mouth pressures (PI max). The test would be performed using Jaeger Viasys 5.0 system as per American Thoracic Society(ATS) criteria. The 6 minute walk test will be administered in a 30 m corridor in accordance with the guidelines recommended by ATS.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of mild to severe asthma according to GINA guidelines
  • Age 30 to 65 years
  • Symptomatic – Dyspnoea
  • Patients referred by the Physicians for Inspiratory muscle training.

排除标准

  • Patients who are deemed to be too sick to perform the 6 min walk test or other study related tests.
  • The presence of a significant comorbid disease that might interfere with the training process or place the patient at undue risk for exercise training 3.Inspiratory muscle training within the past 12 months.
  • 4.Subjects unwilling to give informed consent.

结局指标

主要结局

PI max-Measurement of the maximum static Inspiratory pressure that a subject can generate at the mouth (PImax) is a simple way to gauge inspiratory muscle strength

时间窗: PI max-6 weeks

次要结局

  • PE max,6 minute walk test,Asthma Control test,St.George Respiratory Disease Questionnaire(6 weeks)

研究者

申办方类型
Private medical college

研究点 (1)

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