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临床试验/CTRI/2025/10/095932
CTRI/2025/10/095932尚未招募不适用

A study to compare the effect of Intradialytic therapy, Progressive resisted exercises and Conventional exercises on muscle strength, markers of bone mineral metabolism and quality of life in patients with chronic kidney disease

KBaby Carolin1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2025年10月25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
99
试验地点
1
主要终点
1.To assess the muscle strength

研究概览

简要总结

Chronic kidney disease (CKD) is a progressive condition where patients often require long-term hemodialysis. Individuals on maintenance hemodialysis frequently experience muscle weakness, bone mineral imbalance, and poor quality of life due to reduced physical activity and treatment-related complications. Exercise interventions have been shown to improve strength, functional capacity, and well-being in patients with CKD, but there is limited evidence comparing different forms of exercise in this population.

The purpose of this study is to compare the effects of three different exercise interventions on patients undergoing maintenance hemodialysis: (1) intradialytic exercise performed during dialysis sessions, (2) progressive resisted exercises conducted outside of dialysis, and (3) conventional exercises. The study will evaluate changes in muscle strength, bone mineral metabolism, and quality of life in these groups.

This will be a randomized controlled trial conducted among patients with CKD undergoing regular hemodialysis. Eligible participants will be randomly assigned to one of the three groups. Standardized protocols for each exercise type will be followed under supervision. Outcome measures will include assessment of muscle strength, biochemical markers of bone mineral metabolism, and validated quality of life questionnaires.

It is expected that the findings of this study will provide evidence on the most effective exercise strategy for improving physical health, bone status, and overall quality of life in patients with CKD on hemodialysis. This may help in developing exercise-based rehabilitation protocols as a part of routine dialysis care.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • On maintenance Hemodialysis 3 sessions/week for at least 6 months.
  • No history of Myocardial Infarction for past 3 months.
  • Fit for functional assessment by incremental shuttle walk(ISWT) test.
  • patient should meet 600 meters distance.
  • Patients with CKD stage Patients with self reported physical inactivity.
  • Non wheelchair bound.
  • Able to provide informed consent.

排除标准

  • Patients with Malignancy Patients with CKD stage 1 and 2 Severe musculoskeletal or neurological disorders.
  • Uncontrolled hypertension or arrhythmias.
  • Medications that could interfere with bone metabolism.
  • Active bone disease not related to chronic kidney disease/metabolic bone disease.
  • Patients with peritoneal dialysis Lower limb disabilities/Amputation.
  • Deep Vein Thrombosis.
  • Femoral fistula.
  • use of medications that might influence PTH, calcium, or phosphorus levels.

结局指标

主要结局

1.To assess the muscle strength

时间窗: 24 weeks

Upper and lower limb

时间窗: 24 weeks

2.To assess the bone mineral metabolism:

时间窗: 24 weeks

次要结局

  • To assess the Anxiety and depression

研究者

发起方
KBaby Carolin
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

K .Baby Carolin

Dr.MGR Educational and Research Institute

研究点 (1)

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