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临床试验/CTRI/2025/09/094647
CTRI/2025/09/094647尚未招募不适用

Effectiveness of inspiratory muscle trainer on pulmonary function and functional capacities in phase 1 cardiac rehabilitation

Dr Nigam Subhash Nagdeve1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年9月11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
130
试验地点
1
主要终点
Inspiratory muscle trainer

研究概览

简要总结

Cardiac rehabilitation is defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) as the delivery of all-inclusive, long-term services that include medical evaluation, prescription exercise, modification of cardiac risk factors, education, counseling, and behavioral interventions. The inspiratory muscle trainer device benefits includes improved pulmonary function, respiratory muscle strength and endurance, functional capacity, physical activity, and health-related quality of life used  patients.Efficacy of inspiratory muscle trainer during Phase 1 of cardiac rehabilitation has not been well studied.

This randomized clinical trial aimed to evaluate and  the effects of Inspiratory muscle trainer  who underwent  Phase 1 of their cardiac rehabilitation.

Procedure : Participants will be selected and screened based on inclusion and exclusion criteria. Details about the study and intervention will be explained to the participants and an informed written consent form will be obtained. Patient’s will be Randomly divided through block randomisation method into Group A (control  ) and Group B ( IMT). Outcomes will be assessed on pod 1 and treatment will be given from POD 2 to POD 6 to Patients who underwent through cardiac rehabilitation  On Postoperative day 6 outcomes will be reassessed. Data will be collected from both groups and analyzed for significant differences in pulmonary function and airway clearance improvements. Statistical tests will be used to compare the efficacy of inspiratory muscle trainer  devices in enhancing respiratory outcomes in phase 1 cardiac rehab patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 A minimum 40% ejection fraction 2 Heart valve surgery, left or right 3 Minimum age of eighteen years 4 NYHA I–III stable heart failure CABG 5 Coronary artery percutaneous intervention.

排除标准

  • BP higher than 200mg in systolic and 110 in diastolic ,ischemic ECG alteration, uncontrolled tachycardia instable angina, AV block of third degree.

结局指标

主要结局

Inspiratory muscle trainer

时间窗: Postoperative day 1 | Postoperative day 6

次要结局

  • 6 Minute walk test(Postoperative day 1)

研究者

发起方
Dr Nigam Subhash Nagdeve
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nigam Subhash Nagdeve

Datta Meghe College Of Physiotherapy ,Nagpur

研究点 (1)

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