Effect of Intradialytic Exercise Program on Sleep Quality, Depression and Anxiety in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in sleep quality
研究概览
简要总结
this study aims To assess the effect of intradialytic exercise program on sleep quality, depression and anxiety in HD Patients.
详细描述
Intradialytic exercise is a common recommendation given to encourage patients to be physically active. Previous studies have suggested that intradialytic exercise is effective in reducing fatigue severity, improving sleep quality, enhancing exercise tolerance, improving quality of life and even psychological status. Research also revealed that intradialytic exercise can increase the efficacy of dialysis, subsequently alleviating inflammation, improving nutrition and bone mineral density. Patients typically undergo two or three hemodialysis sessions a week, with each session lasting for approximately 4 hours. Since many patients maintain bed rest during HD sessions, intradialytic exercise can be a potentially useful approach to improve their health without consuming extra time during the interdialytic period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESKD patients on maintenance hemodialysis for more than three months.
- •Age more than 18 years.
排除标准
- •Mentally or physically unfit patients or with severe psychiatric illness.
- •Patients who receive any psychotropic medications.
- •Patients with overt ischemic heart disease or cardiac decompensation.
- •Anemic patients (Hb ≤ 8 mg/dl).
- •Patients presented with severe bone pains or muscle weakness secondary to chronic kidney disease-mineral and bone disorder (CKD-MBD).
- •Patients with advanced lower limbs joints disease.
- •Lower limb amputation.
研究组 & 干预措施
Exercise group
50 patients will undergo Exercise training program for twelve weeks during hemodialysis session.
- Type of exercise: aerobic exercise training sessions using a lower limb ergometer.
- Frequency: three times per week.
- Duration: thirty minutes per session.
干预措施: intradialytic exercise (Other)
control group
50 patients will not perform exercise during hemodialysis session
干预措施: control group (Other)
结局指标
主要结局
change in sleep quality
时间窗: 12 weeks
by using The Pittsburgh sleep Quality Index (PSQI).
change in depression scale
时间窗: 12 weeks
by using Beck Depression inventory (BDI)
change in anxiety level
时间窗: 12 weeks
by using The Beck Anxiety Inventory (BAI) scoring
次要结局
- effect on dialysis adequacy(12 weeks)
- effect on lipid profile(12 weeks)
研究者
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Associate professor
Alexandria University