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临床试验/CTRI/2024/11/077307
CTRI/2024/11/077307尚未招募1 期

Efficacy of different Inspiratory and Expiratory Muscle Training protocols on Cardiopulmonary Parameters in Dialysis Dependent Chronic Kidney Disease Patients: A Comparative Study

SGT University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
48
试验地点
1
主要终点
1 Inspiratory Muscle strength

研究概览

简要总结

CKD is not only a major risk factor for dialysis but also increased the risk of cardiovascular, respiratory, musculoskeletal, immune, endocrine and metabolic system. The reduced lung function leads to endothelial alteration. The cardiovascular diseases are collectively the main cause of death in patients with undergoing hemodialysis. The reduction in the inspiratory and expiratory muscle strength, is evaluated by maximum inspiratory pressure(MIP). Thus inspiratory muscle training could improve functional capacity in hemodialysis patient. However, the effect of threshold IMT and threshold PEP IMT with integrated renal rehabilitation have not yet compared with the cardiopulmonary complication in CKD patient.

Null Hypothesis

H01.   The effect of Threshold IMT with integrated rehabilitation will not produce any change in the muscle strength, PFT, GFR, cardiorespiratory fitness in dialysis depended CKD patient.

H12 The effect of Threshold PEP IMT with integrated rehabilitation will not produce any change in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiorespiratory fitness in dialysis-dependent CKD patients.

H23The effect of threshold IMT and threshold PEP IMT with integrated renal rehabilitation there will be no comparison in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiopulmonary fitness in dialysis-dependent CKD patients.

Alternate Hypothesis

H1. The effect of Threshold IMT with integrated rehabilitation will produce changes in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiorespiratory fitness in dialysis-dependent CKD patients.

H2The effect of Threshold PEP IMT with integrated rehabilitation will produce changes in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiorespiratory fitness in dialysis-dependent CKD patients.

H3 The effect of threshold IMT and threshold PEP IMT with integrated renal rehabilitation there will be a comparison in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiopulmonary fitness in dialysis-dependent CKD patients.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with chronic kidney disease who are on hemodialysis for more than 3 months with or without cardiopulmonary complications.
  • The study will include men and women older than 18 years.

排除标准

  • History of arrhythmias (6 months)
  • Unstable angina.
  • Severe lung carcinoma
  • Severe valve disease
  • Spinal cord injured patient
  • Patient with lower limb amputation
  • Decompensated Diabetes Mellitus and Hypertension.

结局指标

主要结局

1 Inspiratory Muscle strength

时间窗: Day 1 Assessment | 4th Week Assessment | 8th Week Assessment

2 Expiratory Muscle strength

时间窗: Day 1 Assessment | 4th Week Assessment | 8th Week Assessment

次要结局

  • 1. Diaphragm thickness(2. Pulmonary function test)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Neha Reyalch

S.G.T University

研究点 (1)

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