Effect of Intradialytic Resistance Versus Aerobic Exercise on Cardiovascular System in Patients on Regular Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Systolic blood pressure measurement
研究概览
简要总结
The purpose of the study is to compare the effect of resistance exercise and aerobic exercise on intradialytic hypotension in patients undergoing hemodialysis.
详细描述
Chronic kidney disease (CKD) is one of the leading causes of global morbidity and mortality. In the 2019 Global Burden of Disease study, CKD was among the top ten risks associated with the highest number of deaths worldwide, with a death toll of 3.16 million deaths.
Patients undergoing dialysis in Egypt in 2020 are mostly men (59%), and half of them are aged ≥55 years. Hypertension is the most common cause of end-stage kidney disease at 41%, followed by diabetes at 14%, whereas glomerulonephritis is the primary diagnosis in 3% of patients undergoing dialysis.
Hemodialysis (HD), continuous ambulatory peritoneal dialysis, and kidney transplantation are the three main modalities of renal replacement therapy. Hypotension is the most reported complication of routine outpatient HD treatments.
Toxic substances, also called uremic toxins, in the blood result in malaise, paraesthesia, mental impairment, peripheral circulatory disturbance, and muscle dysfunction.
While patients exercise during dialysis, those toxins move through the dialyzer with a large flux from the tissue to the vascular compartment. It results in increased muscle blood flow and opened capillary surface area. Besides, the intradialytic exercise showed not only better adoption and adherence but also a lower drop-out and greater compliance.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD) in which on maintenance regular HD (three sessions/week (on alternate days), for four hours/session for more than a year to five years when starting the study.
- •Both gender male and female aged from 45 to 60 years old.
- •Patients with intradialytic hypotension sudden drops of systolic pressure of more than 20 mm Hg or diastolic pressure of more than 10 mmHg.
- •Receiving hemodialysis (HD) through uncomplicated arm arteriovenous (A-V) fistula.
- •Patients with Body Mass Index (BMI): 18,5 < 30kg/m
- •In a stable medical, clinical, and hemodynamic condition
- •Untrained at baseline and did not participate in any regular physical activity before.
排除标准
- •Severe Chest diseases (either obstructive or restrictive).
- •Clinical signs of a severe cardiac event. (eg, severe atherosclerosis, congestive heart failure),
- •Severe psychiatric or cognitive impairment, who unable to follow comment.
- •Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
- •Patients with severe self-limiting illness (e.g., cancer).
- •Patients with Body Mass Index (BMI) > 30kg/m
- •Previous renal transplantation patients.
- •Pregnant females or became pregnant during the study.
- •Patients started HD in less than a year or more than 5 years.
- •Hospitalized during the prior month.
- •Patients who were irregular in HD or not adherent to the exercise program.
结局指标
主要结局
Systolic blood pressure measurement
时间窗: 12 weeks
Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. Systolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.
Diastolic blood pressure measurement
时间窗: 12 weeks
Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. diastolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.
Peripheral oxygen saturation
时间窗: 12 weeks
Pulse oximetry is a non-invasive method used to measure the oxygen saturation level (SpO2) in the blood, providing an estimate of how much oxygen the hemoglobin in red blood cells is carrying. It provides data on oxygen delivery to extremities, which may be impaired in circulation issues. Normally, its value is 95-99%.
Creatinine level
时间窗: 12 weeks
Blood analysis will be used to measure creatinine level for all patients before and after intervention. Its values vary by sex; 0.6-1.2 mg/dl for men and 0.5-1.1 mg/dl for women.
Ankle-Brachial Index (ABI)
时间窗: 12 weeks
This non-invasive test compares blood pressure in the ankles to blood pressure in the arms. An ABI below 0.9 usually suggests peripheral artery disease (PAD), a common cause of circulatory issues.
blood urea level
时间窗: 12 weeks
Blood analysis will be used to measure blood urea for all patients before and after intervention. its normal value ranges from 17-43 mg/dl.
blood urea nitrogen test
时间窗: 12 weeks
Blood analysis will be used to measure blood urea nitrogen for all patients before and after intervention. its normal value ranges from 7-20 mg/dl.
serum albumin
时间窗: 12 weeks
Blood analysis will be used to measure serum albumin for all patients before and after intervention. its normal value in adults is typically 3.5-5.0 g/L.
次要结局
- Six minutes walking Test (6 MWT)(12 weeks)
- The Kidney Disease Quality of Life Short Form (KDQOL-SF)(12 weeks)
研究者
Yasmin Mohamed Mahmoud Gouda
Principal investigator
Cairo University