跳至主要内容
临床试验/CTRI/2024/01/062069
CTRI/2024/01/062069尚未招募1 期

Impact of Renal rehabilitation through intra dialytic exercises in patients with end stage Chronic Kidney Disease (CKD) on hemodialysis – a prospective randomized control study

Sakra World Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Functional capacity 6 Minute Walk Test

研究概览

简要总结

·         Chronic kidney diseases (CKD), worldwide, are rising markedly and becoming a priority public health problem.

·         The progression of CKD causes functional limitation and severe disability with poor quality of life *(*Domenico Intiso, 2014). Chronic Kidney Diseases are the 6th fastest cause of death and suffering due to high morbidity

·         Renal rehabilitation (RR) is a coordinated, multifaceted intervention designed to optimize a patient’s physical, psychological, and social functioning, in addition to stabilizing, slowing, or even reversing the progression of renal deterioration, thereby reducing morbidity and mortality (Masahiro Kohzuki, 2013)

  • Intradialytic exercise is a recommendation given to encourage renal patients to be physically active. Studies have suggested that intradialytic exercise is effective in reducing fatigue severity, improving sleep quality, enhancing exercise tolerance, improving quality of life. Research also indicates that intradialytic exercise can increase the efficacy of dialysis, subsequently alleviating inflammation, improving nutrition and bone mineral density. (Pu J, et al. BMJ Open 2019)

1. Research Objective:

To compare the effects of supervised intradialytic exercises (Experimental Group) Versus conventional care (Control Group) in patients with end stage Chronic Kidney Disease (CKD) who undergo hemodialysis

2. Rationale:

There has been evidence that Intradialytic Rehabilitation (IDR) helps to improve a patient’s overall functional status and quality of life.

However, such intervention is not practiced in India and there is a dearth of clinical studies done on Indian population.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age group more than 18 years Patients with end stage Chronic Kidney Disease(CKD) undergoing hemodialysis Patients who are able to stand and walk.

排除标准

  • Patients with unstable haemodynamic parameters Symptomatic ischemic heart disease Patient undergone any recent surgeries Patients with cognitive impairment Lower limb amputation.

结局指标

主要结局

Functional capacity 6 Minute Walk Test

时间窗: Baseline, 3months and 6months

Inspiratory muscle strength

时间窗: Baseline, 3months and 6months

次要结局

  • Kidney Quality of Life(Baseline, 3months & 6months)

研究者

发起方
Sakra World Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Saril V S

Sakra World Hospital

研究点 (1)

Loading locations...

相似试验