The Effect of Aerobic Exercise and Physiological Ischemic Training on VEGF, Interleukin-6, Interleukin-10, Cardiorespiratory Fitness, Muscle Strength, and Quality of Life in Patients With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vascular Endothelial Growth Factor (VEGF) Level
研究概览
简要总结
This study aims to compare the effects of aerobic exercise (AE) and physiological ischemic training (PIT) on inflammatory and angiogenesis biomarkers (VEGF, IL-6, IL-10), cardiorespiratory fitness, muscle strength, and quality of life in patients with grade 2 primary hypertension (HT2). This randomized controlled trial will involve 60 HT2 patients from Pratama and Utama Medika Antapani Clinic, who will be assigned to either AE or PIT groups. The intervention will last 6 weeks, and outcomes measured will include biomarker levels, VO2max, 6-minute walk distance (6-MWD), maximum voluntary contraction (MVC), and SF-36 questionnaire scores.
详细描述
Background: Grade 2 primary hypertension (HT2) can negatively affect cardiovascular health and quality of life. Physical exercise is a non-pharmacological intervention that may modulate inflammatory and angiogenesis biomarkers, as well as improve fitness and patient-reported outcomes. This study aims to compare the effects of aerobic exercise (AE) and physiological ischemic training (PIT) on HT2 patients.
Methods: This randomized controlled trial will include 60 HT2 patients from Pratama and Utama Medika Antapani Clinic. Participants will be randomly assigned to AE or PIT groups. The intervention will last 6 weeks. Outcomes to be measured include vascular endothelial growth factor (VEGF), interleukin-6 (IL-6), interleukin-10 (IL-10), cardiorespiratory fitness (VO2max, 6-minute walk distance [6-MWD]), muscle strength (maximum voluntary contraction [MVC]), and quality of life (SF-36 questionnaire).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hypertension patients aged 18-65 years
- •Diagnosed with grade 2 primary hypertension
- •Willing to participate in the study
排除标准
- •Patients with unstable angina
- •Malignant arrhythmias and high atrioventricular block
- •Unstable hemodynamics
- •Uncontrolled hypertension
- •Acute pericarditis
- •Severe valvular heart disease
- •Chronic obstructive pulmonary disease
- •Cor pulmonale and pulmonary vascular disease
- •Thrombophlebitis
- •Intermittent claudication
- •Cognitive impairment
- •Uncooperative subjects
- •Subjects experiencing infection or inflammation
- •Subjects with neuromuscular disorders that may affect the study results
- •Subjects with musculoskeletal disorders that may affect the study results
- •Complications or comorbidities such as cerebrovascular disease, CAD, atheroma plaques on imaging, heart failure, PAD, and atrial fibrillation.
研究组 & 干预措施
Aerobic Exercise (AE)
Participants will perform a structured aerobic exercise program for 6 weeks, supervised by trained personnel. Outcomes measured include biomarkers (VEGF, IL-6, IL-10), cardiorespiratory fitness (VO2max, 6-minute walk distance), muscle strength (MVC), and quality of life (SF-36).
干预措施: Aerobic Exercise (AE) (Behavioral)
Physiological Ischemic Training (PIT)
articipants will perform a 6-week physiological ischemic training program, supervised by trained personnel. Outcomes measured include biomarkers (VEGF, IL-6, IL-10), cardiorespiratory fitness (VO2max, 6-minute walk distance), muscle strength (MVC), and quality of life (SF-36).
干预措施: Physiological Ischemic Training (PIT) (Behavioral)
结局指标
主要结局
Vascular Endothelial Growth Factor (VEGF) Level
时间窗: Measured at baseline and after 6 weeks of intervention
Change in circulating vascular endothelial growth factor (VEGF) concentration in peripheral blood, measured using a standardized laboratory assay, as an indicator of angiogenic response to the exercise intervention.
次要结局
- Interleukin-6 (IL-6) Level(Baseline and 6 weeks)
- Interleukin-10 (IL-10) Level(Baseline and 6 weeks)
- 6-Minute Walk Distance (6-MWD)(Baseline and 6 weeks)
- Muscle Strength (Maximum Voluntary Contraction, MVC)(Baseline and 6 weeks)
- Quality of Life (36-Item Short Form Health Survey, SF-36)(Baseline and 6 weeks)
研究者
Arnengsih Nazir
Principal Investigator
Universitas Padjadjaran