跳至主要内容
临床试验/CTRI/2019/08/020848
CTRI/2019/08/020848招募中不适用

A Randomized control trial to study the Effect of Intradialytic Exercises on Maximal Oxygen Consumption and Quality of life Undergoing Haemodialysis in Indian Population

Apollo Hospitals Educational and Research Foundation AHERF1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年1月9日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
1.SF-36. 2.Pittsburgh sleep quality index 3. Vo2 max 4. Rate of perceived exertion

研究概览

简要总结

Purpose and significance of the study

The purpose of this interventional study is to examine the effect of intradialytic exercises on maximal oxygen consumption in patients undergoing Haemodialysis in Indian population.

Significance of the study

  1. By obtaining results from this study we would be able to implement exercise program in patients who are undergoing haemodialysis more frequently.

  2. Effect of physical activity in improving their quality of life can be easily assessed and better measures can be taken to prevent further complications of long standing hours of haemodialysis.

Objectives of the study

1.     To find the effect of intradialytic exercises on quality of life in chronic kidney disease patient undergoing haemodialysis in India.

2.     To find the difference in physical performance pre and post physical therapy session.

3.     To find the difference in maximal oxygen consumption after the 3 months of physiotherapy intervention.

Expected outcome

Significant relationship between intradialytic exercises and maximal oxygen consumption improving quality of life, and general health outcomes of patient who are undergoing haemodialysis would be ascertained .Based on the protocol a regimen would be created for patients undergoing haemodialysis for betterment of physical performance.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • 1.Age -30-60 2.Haemoglobin > 10 mmHg 3.No hospitalizations during the previous 3 months, except for vascular access repair; 4.No amputations or prostheses in lower extremities 5.Able to ambulate and ability to complete all study protocol tests 6.Likelihood of good compliance to the protocol.

排除标准

  • 1.Acute infectious or other inflammatory illnesses 2.Current heart failure, lung failure, severe liver disease, or active cancer except basal cell carcinoma 3.Myocardial infarction or angina pectoris within the past 12 months.
  • 4.Disapproval by physician 5.pregnancy, kidney transplant within 6 months 6.visual or hearing impairment 7.Inability to give informed consent 8.Patient having femoral fistula as access for Haemodialysis.

结局指标

主要结局

1.SF-36. 2.Pittsburgh sleep quality index 3. Vo2 max 4. Rate of perceived exertion

时间窗: 3 months

次要结局

  • 1. Improved quality of life.(2. Improved functional capacity.)

研究者

发起方
Apollo Hospitals Educational and Research Foundation AHERF
申办方类型
Research institution and hospital

研究点 (1)

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