Comparing the Effect of Intradialytic and Home-Based Exercise on Health Outcomes, Quality of Life, Self-Esteem, and Sexual Function in Female Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
This randomized controlled trial compared intradialytic exercise with home-based exercise in married female patients receiving maintenance hemodialysis. Ninety participants were randomly assigned in equal numbers to an intradialytic exercise group, a home-based exercise group, or a control group. Both exercise programs continued for 12 weeks.
The study evaluated whether exercise performed during dialysis or at home could improve quality of life, self-esteem, sexual function, and selected clinical and laboratory outcomes. Quality of life was assessed using the 36-Item Short Form Survey, self-esteem using the Rosenberg Self-Esteem Scale, and sexual function using the Female Sexual Function Index. Laboratory assessments included calcium, phosphorus, intact parathyroid hormone, albumin, C-reactive protein, hemoglobin, sodium, and potassium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients older than 18 years.
- •Clinically stable.
- •Receiving regular maintenance hemodialysis three times per week for at least three months.
- •Able to perform mild- to moderate-intensity exercise.
排除标准
- •Physical limitations preventing exercise.
- •Acute illness.
- •Unstable cardiovascular disease.
- •Severe orthopedic or neurological disorders.
- •Cognitive impairment affecting cooperation.
- •Dialysis instability.
- •Severe chronic kidney disease-mineral and bone disorder.
- •Significant anemia.
- •Retinal hemorrhage.
- •History of hyperthyroidism.
结局指标
主要结局
Health-Related Quality of Life
时间窗: Baseline and 12 weeks
Change in Health-Related Quality of Life was assessed by the 36-Item Short Form Survey. The 36-Item Short Form Survey consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, energy/fatigue, social functioning, role limitations due to emotional problems, and emotional well-being. Each domain is scored from 0 to 100, with 0 representing the lowest possible health status and 100 representing the highest possible health status. Higher scores indicate better health-related quality of life. The validated Arabic version was used.
Self-Esteem
时间窗: Baseline and 12 weeks
Change in Self-Esteem was assessed by the Rosenberg Self-Esteem Scale. The Rosenberg Self-Esteem Scale consists of 10 items assessing global self-esteem, including five positively worded and five negatively worded statements. Higher total scores indicate higher self-esteem.
Female sexual function
时间窗: Baseline and 12 weeks
Change in Female Sexual Function was assessed by the Female Sexual Function Index. The Female Sexual Function Index consists of 19 items covering six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2 to 36, with higher scores indicating better sexual function. The validated Arabic version was used.
次要结局
未报告次要终点
研究者
Hebatuallah Abdelhaleem Elhabiby
Lecturer of Nephrology and Internal Medicine
Tanta University