An interventional study of Aerobic Exercise (AE) and Physiological Ischemic Training (PIT) in Primary Hypertension, Grade 2, sponsored by Universitas Padjadjaran. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Universitas Padjadjaran · Not applicable, Interventional, and Treatment
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).
527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.
This study's enrollment of 60 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.
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Exclusion Criteria:
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)
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 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)
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).
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
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.
Time frame: Baseline and 6 weeks
Interleukin-10 (IL-10) Level
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.
Time frame: Baseline and 6 weeks
6-Minute Walk Distance (6-MWD)
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.
Time frame: Baseline and 6 weeks
Muscle Strength (Maximum Voluntary Contraction, MVC)
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.
Time frame: Baseline and 6 weeks
Quality of Life (36-Item Short Form Health Survey, SF-36)
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.
Time frame: Baseline and 6 weeks
Plan to share: Yes — 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.
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Universitas Padjadjaran