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临床试验/NCT07183696
NCT07183696已完成不适用

Effect of Breath Booster Training on Respiratory Muscle Strength and Quality of Life in Hemodialysis Patients

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Respiratory Muscle Strength measured using Respiratory Pressure Manometers

研究概览

简要总结

This study investigates the effect of breath booster training on respiratory muscle strength and quality of life in patients undergoing hemodialysis. It aims to determine whether targeted respiratory training can improve pulmonary function, enhance physical performance, and positively impact overall well-being in this population.

详细描述

Detailed Description Statement of the problem Does Breath Booster training have an effect on respiratory muscle strength and quality of life in hemodialysis patients? Purpose of the study

The study aims to:

Investigate the effect of the Breath Booster device on respiratory muscle strength in patients undergoing dialysis.

Evaluate the impact of the Breath Booster device on the quality of life of patients undergoing dialysis.

Assess the effect of the Breath Booster device on exercise capacity in dialysis patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Fifty patients will be included in this study.
  • Their ages will range from 50 to 60 years.
  • Patients with end-stage renal disease (grade 5) receiving hemodialysis.
  • Patients on hemodialysis for around 1 to 3 years.
  • They will be able to follow instructions during evaluation and treatment.

排除标准

  • Diabetes Mellitus,
  • Morbid obesity with a BMI of more than 35 kg/m
  • Hearing or visual impairments.
  • Any severe chest diseases like COPD.
  • Certain contraindications for the use of the Breath Booster. Individuals with severe respiratory conditions such as unstable asthma, or emphysema, or those who have recently undergone lung surgery
  • Uncontrolled seizures.

研究组 & 干预措施

Placebo

Placebo Comparator

will receive respiratory physical therapy sessions in the form of breathing exercises, chest percussion, and vibration 3 times per week during dialysis sessions for 6 weeks

干预措施: breathing exercises (Other)

Intervention Group

Experimental

will receive respiratory physicaltherapy sessions in the form of breathing exercises, chest percussion, and vibration 3 times per week during dialysis sessions for 6 weeks and training on the breath booster device at the same session

干预措施: breathing exercises (Other)

结局指标

主要结局

Respiratory Muscle Strength measured using Respiratory Pressure Manometers

时间窗: 6 weeks

Outcomes include maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), recorded in cmH₂O. Higher values indicate greater respiratory muscle strength.

Health-Related Quality of Life assessed by the 36-Item Short Form Health Survey

时间窗: for 6 weeks

It includes eight domains (physical functioning, role limitations, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Scores are transformed to a 0-100 scale, where 0 = worst health and 100 = best health. Higher scores indicate better health-related quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh Eldaly

director of scientific research committee

Cairo University

研究点 (2)

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