Aerobic Exercise vs Physiological Ischemic Training in Stage 2 Hypertension

Universitas Padjadjaran60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Aerobic Exercise (AE)BEHAVIORAL

Participants will perform a structured aerobic exercise program for 6 weeks under supervision. The program is designed to improve cardiovascular fitness. Outcomes to be measured include biomarkers (VEGF, IL-6, IL-10), cardiorespiratory fitness (VO2max, 6-minute walk distance), muscle strength (MVC), and quality of life (SF-36)

Physiological Ischemic Training (PIT)BEHAVIORAL

Participants will perform a structured physiological ischemic training program for 6 weeks under supervision. The program is designed to modulate angiogenesis and inflammatory biomarkers. Outcomes to be measured include biomarkers (VEGF, IL-6, IL-10), cardiorespiratory fitness (VO2max, 6-minute walk distance), muscle strength (MVC), and quality of life (SF-36).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Primary hypertension patients aged 18-65 years 2. Diagnosed with grade 2 primary hypertension 3. Willing to participate in the study Exclusion Criteria: 1. Patients with unstable angina 2. Malignant arrhythmias and high atrioventricular block 3. Unstable hemodynamics 4. Uncontrolled hypertension 5. Acute pericarditis 6. Severe valvular heart disease 7. Chronic obstructive pulmonary disease 8. Cor pulmonale and pulmonary vascular disease 9. Thrombophlebitis 10. Intermittent claudication 11. Cognitive impairment 12. Uncooperative subjects 13. Subjects experiencing infection or inflammation 14. Subjects with neuromuscular disorders that may affect the study results 15. Subjects with musculoskeletal disorders that may affect the study results 16. Complications or comorbidities such as cerebrovascular disease, CAD, atheroma plaques on imaging, heart failure, PAD, and atrial fibrillation.

Outcomes

Primary Outcomes

Vascular Endothelial Growth Factor (VEGF) Level

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.

Time frame: Measured at baseline and after 6 weeks of intervention

Secondary Outcomes

Interleukin-6 (IL-6) Level

Change in circulating interleukin-6 (IL-6) concentration in peripheral blood, measured using enzyme-linked immunosorbent assay (ELISA), as an indicator of systemic inflammatory response.