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临床试验/CTRI/2023/09/058052
CTRI/2023/09/058052尚未招募不适用

Effectiveness of intradialytic exercise on quality of life, functional ability and incidence of intradialytic hypotension among patients undergoing hemodialysis at a tertiary care hospital: a randomized controlled trial.

Intramural Research Fund Committee1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
To assess the effectiveness of intradialytic exercise on quality of life among patients undergoing hemodialysis.

研究概览

简要总结

This study is a randomized controlled trial to assess the effectiveness of intradialytic exercise on quality of life, functional ability and incidence of intradialytic hypotension among patients undergoing hemodialysis at a tertiary care hospital. Patients who met the inclusion criteria will be enrolled from hemodialysis unit by consecutive sampling method. Informed consent will be obtained and the procedure will be performed for 15 minutes during the first half of hemodialysis. Initial data for every participant will be collected before the beginning of the procedure: Sociodemographic data, height, weight, BMI , number of dialysis per week, duration of each dialysis, comorbidities. Assessment of quality of life and functional ability will be done at the time of enrollment , after 1 month and after 3rd month of enrollment at the end of hemodialysis session. blood pressure will be assessed before , during and after each hemodialysis session for 3 months. Quality of life will be assessed by using KDQOL  tool and functional ability will be assessed by 6 minute walk test.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Age above 18 years.
  • •History of Hemodialysis for more than 6 months.
  • •Patients undergoing Hemodialysis for 4 hours, three times per week.

排除标准

  • •History of MI in last 6 months.
  • •Patient with Heart Failure NYHA stage more than three.
  • •Patients with symptomatic Cardiovascular disease.
  • •Patients with altered sensorium.
  • •Patients with any physical disability.
  • •Patients with unstable medical illness due to acute or chronic illness.

结局指标

主要结局

To assess the effectiveness of intradialytic exercise on quality of life among patients undergoing hemodialysis.

时间窗: 3 months

次要结局

  • To assess the effectiveness of intradialytic exercise on functional ability among patients undergoing hemodialysis.(3 months)
  • To identify the incidence of intradialytic hypotension among patients undergoing hemodialysis.(3 months)

研究者

发起方
Intramural Research Fund Committee
申办方类型
Research institution and hospital

研究点 (1)

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