Aerobic Exercise vs Physiological Ischemic Training in Stage 2 Hypertension

January 29, 2026 updated by: Arnengsih Nazir, Universitas Padjadjaran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Hasan Sadikin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: Aerobic Exercise (AE)
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)
Experimental: 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).
Behavioral: Physiological Ischemic Training (PIT)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline and after 6 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2023

Primary Completion (Actual)

December 5, 2023

Study Completion (Actual)

February 5, 2024

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKFR-202502.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data, after de-identification, will be made available to qualified researchers upon request. Requests will be reviewed by the study team and shared under data use agreements to ensure participant privacy and compliance with ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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