Aerobic Exercise vs Physiological Ischemic Training in Stage 2 Hypertension

NCT07375407 | Completed

• 1 other identifier: IKFR-202502.02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Hypertension, Grade 2

Keywords

Cardiorespiratory Fitness; Interleukin-6; Interleukin-10; Quality of Life; Vascular Endothelial Growth Factor A

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured at baseline and after 6 weeks of intervention

Secondary Outcomes (5)

• 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

Study Arms (2)

Aerobic Exercise (AE)

EXPERIMENTAL

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)

Physiological Ischemic Training (PIT)

EXPERIMENTAL

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)

Interventions

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).

Physiological Ischemic Training (PIT)

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)

Aerobic Exercise (AE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan sadikin general hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Essential Hypertension; Lymphoma, Follicular

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: August 5, 2023
• Primary Completion: December 5, 2023
• Study Completion: February 5, 2024
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)