Effects of Supervised Exercise Training on Red Blood Cell Membrane Protein-Regulated Deformability in Patients With End-Stage Renal Disease Receiving Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in Maximal Erythrocyte Elongation Index (EImax)
研究概览
简要总结
This study evaluated red blood cell function and aerobic capacity in adults receiving maintenance hemodialysis and in healthy reference participants. Participants receiving hemodialysis were included in either a supervised exercise training group or a usual-care group.
The supervised exercise program combined resistance and aerobic exercise performed before hemodialysis. Participants in the exercise group completed repeated assessments across a non-exercise observation period, exercise training, and post-training follow-up. The usual-care group continued usual care without supervised exercise training, and healthy participants served as a reference group.
Assessments included cardiopulmonary exercise testing and blood sampling to evaluate aerobic capacity, red blood cell deformability, and red blood cell characteristics related to membrane function, cell shape, oxidative stress, and calcium-related responses.
详细描述
This prospective study included adults receiving maintenance hemodialysis and healthy reference participants. Participants receiving hemodialysis were included in a supervised exercise training group or a usual-care group. Healthy participants underwent reference assessments without exercise intervention.
Participants in the supervised exercise group first completed a non-exercise observation period and subsequently undertook supervised pre-dialysis exercise training combining resistance and aerobic exercise. Training was performed two to three times per week, with a target of 72 supervised sessions. Exercise sessions were performed approximately 1 to 2 hours before hemodialysis. Aerobic exercise was performed using a cycle ergometer, recumbent stepper, or treadmill, with exercise intensity prescribed according to cardiopulmonary exercise testing. Resistance exercises targeted the upper limbs, lower limbs, and trunk. Blood pressure and electrocardiographic monitoring were performed during exercise sessions.
Participants in the usual-care group continued their usual care without supervised exercise training.
Longitudinal assessments in the exercise group were conducted at study entry, after the non-exercise observation period, during training, after completion of training, and after cessation of training. Assessments included cardiopulmonary exercise testing and blood sampling. Red blood cell analyses included osmotic and mechanical deformability and selected cellular characteristics related to membrane function, cell shape, oxidative stress, and intracellular calcium responses. Healthy participants provided reference data for corresponding physiological and erythrocyte measurements.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 years or older
- •For participants with end-stage renal disease: maintenance hemodialysis for more than 6 months, clinically stable during the previous 3 months, stable medical treatment for at least 6 weeks, nephrologist approval for participation, and Kt/V >1.
- •For healthy reference participants: no history of kidney disease.
- •Willingness to provide written informed consent.
排除标准
- •Hyperkalemia within the previous 3 months.
- •Orthopedic disease, muscle weakness, or other medical, physiological, or psychological conditions preventing exercise training or exercise testing.
- •Pregnancy or planned pregnancy within 1 year.
- •Implanted cardiac devices that prevented achievement of the heart rate required for exercise training.
- •Cardiovascular, metabolic, or other clinical contraindications to exercise testing or training.
研究组 & 干预措施
Usual Care
Participants receiving maintenance hemodialysis continued usual medical care and maintained their usual daily activities without supervised exercise training during the intervention period.
Supervised Exercise Training
Participants receiving maintenance hemodialysis underwent supervised pre-dialysis exercise training combining aerobic and resistance exercise. Training was performed two to three times per week, with a target of 72 supervised sessions.
干预措施: Supervised Exercise Training (Behavioral)
Healthy Reference
Healthy participants without kidney disease received no exercise intervention and underwent study assessments to provide reference data for physiological and red blood cell measurements.
结局指标
主要结局
Change in Maximal Erythrocyte Elongation Index (EImax)
时间窗: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Maximal erythrocyte elongation index (EImax) was derived from ektacytometry measurements obtained across increasing shear stress.
Change in Shear Stress at One-Half Maximal Erythrocyte Deformation (SS1/2)
时间窗: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
The shear stress required to achieve one-half of maximal erythrocyte deformation (SS1/2) was derived from ektacytometry measurements across increasing shear stress.
Change in Hypertonic Osmolality at 50% of Maximal Elongation Index (Ohyper)
时间窗: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Ohyper was assessed by osmotic-gradient ektacytometry and defined as the hypertonic osmolality at 50% of maximal erythrocyte elongation index.
Change in Osmolality at Maximal Elongation Index (Omax)
时间窗: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Omax was assessed by osmotic-gradient ektacytometry and defined as the osmolality at maximal erythrocyte elongation index.
Change in Osmoscan Area Under the Elongation Index-Osmolality Curve
时间窗: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Osmoscan area was assessed by osmotic-gradient ektacytometry and defined as the area under the erythrocyte elongation index-osmolality curve.
次要结局
- Change in Peak Oxygen Uptake (Peak VO₂/kg) Assessed by Cardiopulmonary Exercise Testing(Baseline; 3 months after baseline; after 36 supervised exercise sessions (mid-training); after 72 supervised exercise sessions (end of training); and 3 months after training cessation)
- Change in Erythrocyte Cellular Characteristics(Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation)
- Change in Gardos-Related Erythrocyte Deformability Response(Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation)
- Change in Erythrocyte Intracellular Calcium Response to Oxidative Stress(Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation)
- Change in Erythrocyte Side-Scatter Response to Oxidative Stress(Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation)
研究者
Yu-Chieh Huang
Assistant Professor
Asia University