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临床试验/CTRI/2024/02/063342
CTRI/2024/02/063342尚未招募不适用

Efficacy of Nurse Executed Low Intensity Breathing Based Leg Exercises on Biochemical Parameters, Fatigue and Health-related Quality of Life among Haemodialysis Patients

Maryelizabeth Tidiya Walarine1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2024年3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
190
试验地点
1
主要终点
Fatigue

研究概览

简要总结

End stage renal disease (ESRD) is the 12th leading cause of death worldwide and the 8th in India. Haemodialysis is an important and common treatment method adopted for ESRD. Fatigue is commonly reported among patients receiving haemodialysis and is debilitating.A 12-week breathing-based leg exercise program helped enhance quality of life among haemodialysis patients. In spite of the numerous pieces of evidence regarding  the benefits of exercises, it is not used as part of standard care for patients undergoing haemodialysis.It was found that low-intensity exercise leads to removal of small solutes like potassium. phosphate and urea nitrogen.The current study aims to evaluate the efficacy of nurse-executed low-intensity breathing-based leg exercises on selected biochemical parameters, fatigue, and health-related quality of life among haemodialysis patients and thereby enable patients undergoing haemodialysis to reduce fatigue and maintain a better quality of life with improved biochemical measures.The study tries to evaluate the following hypothesis:

H1: -There will be significant difference in mean pre-test and post-test scores of biochemical parameters among patients undergoing haemodialysis in interventional group with that of control group.

H2: There will be significant difference in mean pre-test and post-test scores of fatigue among patients undergoing haemodialysis in interventional group compared with the control group.

H3: There will be significant difference in mean pre-test and post-test scores of health-related quality of life among patients undergoing haemodialysis in interventional group with that of control group.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients 1) of either gender above 20 years 2) diagnosed as ESRD 3)undergoing haemodialysis treatment three times per week for at least 3 months.

排除标准

  • Patients, 1) with any musculoskeletal and neurological conditions limiting mobility of lower limbs 2) with altered level of consciousness 3) who are undergoing peritoneal dialysis 4) with severe heart disease or unstable angina 5) who have shortness of breath at rest.

结局指标

主要结局

Fatigue

时间窗: Baseline, Week 4, Week 8, Week 12, 3rd month

次要结局

  • Quality of Life
  • S Albumin, S Calcium, S Phosphorus and Vitamin D3(Baseline, Week 4,week Week 8, Week 12, 3rd month)

研究者

发起方
Maryelizabeth Tidiya Walarine
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Maryelizabeth Tidiya Walarine

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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