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临床试验/CTRI/2025/03/082967
CTRI/2025/03/082967尚未招募2 期

Comparison between resistance exercises versus stretching exercises in patients with primary restless leg syndrome of Delhi- NCR- A comparative study

Pooja Maharana1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
1. RLS severity score

研究概览

简要总结

The study compares the effects of resistance exercises and stretching exercises in adults with Primary Restless leg syndrome in Delhi-NCR. RLS is characterised by an uncontrollable urge to move the limbs, often worsening during rest or at night, and can lead to issues like anxiety, depression and cardiovascular problems.

This research will involve dividing participants into two groups: one performing resistance exercises and the other focuses on stretching exercises . Both groups will follow a structured protocol for four weeks, with pre and post intervention measurements of RLS severity, cardiovascular fitness such as blood pressure and heart rate variability and physical performance. RLS severity will be tested by RLS severity scale, Blood pressure through sphygmomanometer, Heart rate variability through Polar H10 chest belt with Kubios software, and physical performance through STS-60.

The study aim to determine which type of exercise is more effective in alleviating symptoms and improving health in individual with RLS.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 65 years IRLS rating score from mild to severe (0-30 points) should meet the diagnostic criteria of IRLSSG should be willing to participate.

排除标准

  • Subjects diagnosed with any neuropathy, renal failure, rheumatoid arthritis, iron deficiency anaemia exposure of drugs which aggravate RLS- neuroleptics, dopamine receptor blocking agents, antidepressants, antihistamines orthopedic condition that limits ambulation pregnant women unwillingness to continue the exercise sessions.

结局指标

主要结局

1. RLS severity score

时间窗: 4 weeks

2. Blood pressure

时间窗: 4 weeks

3. Heart rate variability

时间窗: 4 weeks

次要结局

  • 1. Physical performance by STS-60(4 weeks)

研究者

发起方
Pooja Maharana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Pooja Maharana

SGT University

研究点 (1)

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