跳至主要内容
临床试验/NCT05382468
NCT05382468已完成不适用

An Experimental Study to Assess the Effectiveness of Intradialytic Exercise on Reduction in Fatigue and Muscle Cramps and Improvement in Muscle Strength Among CKD Patients Undergoing Maintenance Haemodialysis at Dialysis Unit.

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Fatigue

研究概览

简要总结

An experimental study to assess the Effectiveness of Intradialytic exercise on reduction in Fatigue and Muscle Cramps and Improvement in Muscle Strength among CKD patients undergoing Maintenance Haemodialysis at dialysis unit of ILBS.

Objectives

Primary objective:

1.To evaluate the effectiveness of the intradialytic exercise on reduction in fatigue and muscle cramps and improvement in muscle strength among patients undergoing hemodialysis at dialysis unit of ILBS.

Secondary objectives:

  1. To find out the association of mean fatigue score with demographic & clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
  2. To find out the association of mean muscle cramps score with the demographic & clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
  3. To find out the association of mean muscle strength score with demographic variables & clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.

详细描述

OPERATIONAL DEFINITIONS Effectiveness: It refers to the degree to which something is successful in producing a desired result (Oxford Dictionaries 2018). In this study it refers to the significant reduction in fatigue & muscle cramps & improvement in muscle strength after intradialytic exercise among patients undergoing maintenance hemodialysis.

Intradialytic exercise: Intradialytic exercise is the exercise performed actively and passively of the affected muscles pertaining at the end of second a hour of hemodialysis.(Sharman 2006). In this study intradialytic exercise comprised of a set warm up, aerobic, active,passive & cool down activities performed by patients during dialysis for a period of 30 min twice or thrice a week regularly for one month & supervised by principle investigator.

Fatigue: Fatigue is a feeling of weariness, tiredness, or lack of energy.( medline plus ). In this study fatigue is a extreme tiredness and inability to function due to lack of energy & slowed movement among the patients undergoing maintenance haemodialysis here its assessed by FACIT-F scale.

Muscle Cramps: A muscle cramp is a strong, painful contraction or tightening of a muscle that comes on suddenly and lasts from a few seconds to several minutes. It often occurs in the lower extremities ( Matthew Varacallo,2020). In this study muscle cramps refers to painful involuntary muscle contraction felt in the calf, gastrocnemius, soleus, hamstring and quadriceps muscles by the patients undergoing haemodialysis as assessed by Modified Penn Spasm Frequency Scale and graded into as mild, moderate, and severe cramps.

Muscle strength: Muscle strength refers to the amount of force a muscle can produce with a single maximal effort.(Jennifer R. Scott ,Heather Black , March 19, 2020),In the current study , Muscle refers to amount of force of calf, gastrocnemius, soleus, hamstring and quadriceps muscles can produce with a single maximum effort as assessed by muscle power grading scale .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The inclusion criteria for the present study is given below
  • •Patient with CKD undergoing maintenance hemodialysis,
  • •Age 18 years or older .
  • •Those who can understand English / Hindi .
  • •Are willing to participate in the study.

排除标准

  • •Patients with CKD & maintenance hemodialysis upper and lower limb pathology such as nerve injury, vascular injury joint irritability, joint effusion.
  • •Patients with lower limb access for dialysis.
  • •Undergoing emergency dialysis.

研究组 & 干预措施

Intradialytic exercise

Experimental

In this study intradialytic exercise comprised of a set warm up, aerobic, active, passive & cool down activities performed by patients during dialysis for a period of 30 min twice or thrice a week regularly for one month & supervised by principle investigator.

干预措施: Intradialytic exercise (Other)

结局指标

主要结局

Fatigue

时间窗: up to 4 weeks

Fatigue is a extreme tiredness and inability to function due to lack of energy \& slowed movement among the patients undergoing maintenance haemodialysis here its assessed by FACIT-F scale.

Muscle Cramps

时间窗: up to 4 weeks

Muscle cramps refers to painful involuntary muscle contraction felt in the calf, gastrocnemius, soleus, hamstring and quadriceps muscles by the patients undergoing haemodialysis as assessed by Modified Penn Spasm Frequency Scale and graded into as mild, moderate, and severe cramps.

Muscle Strength

时间窗: up to 4 weeks

Muscle refers to amount of force of calf, gastrocnemius, soleus, hamstring and quadriceps muscles can produce with a single maximum effort as assessed by muscle power grading scale .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验