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NCT Number: NCT07375407

Aerobic Exercise vs Physiological Ischemic Training in Stage 2 Hypertension

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.

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Key information

Conditions

Primary Hypertension, Grade 2 Cardiovascular Diseases Essential Hypertension Hemic and Lymphatic Diseases Hypertension Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan sadikin general hospital

Bandung, West Java, 40161, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary hypertension patients aged 18-65 years
  • Diagnosed with grade 2 primary hypertension
  • Willing to participate in the study

Exclusion criteria

  • 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.

Treatment and study plan

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).

Primary outcomes

  1. Vascular Endothelial Growth Factor (VEGF) Level

    Time frame: 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.

Secondary outcomes

  1. Interleukin-6 (IL-6) Level

    Time frame: Baseline and 6 weeks

    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.

  2. Interleukin-10 (IL-10) Level

    Time frame: Baseline and 6 weeks

    Change in circulating interleukin-10 (IL-10) concentration in peripheral blood, measured using enzyme-linked immunosorbent assay (ELISA), as an indicator of anti-inflammatory response.

  3. 6-Minute Walk Distance (6-MWD)

    Time frame: Baseline and 6 weeks

    Change in distance walked during the Six-Minute Walk Test (6MWT), measured in meters, as an assessment of functional exercise capacity. Higher distances indicate better functional capacity.

  4. Muscle Strength (Maximum Voluntary Contraction, MVC)

    Time frame: Baseline and 6 weeks

    Change in maximal voluntary contraction (MVC), measured using a handheld or fixed dynamometer and expressed in Newtons (N) or kilograms (kg), as an indicator of muscular strength. Higher values indicate greater muscle strength.

  5. Quality of Life (36-Item Short Form Health Survey, SF-36)

    Time frame: Baseline and 6 weeks

    Change in health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Scores for each domain range from 0 to 100, with higher scores indicating better perceived health status.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 29, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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