Primary Hypertension, Grade 2
Conditions
Keywords
Cardiorespiratory Fitness, Interleukin-6, Interleukin-10, Quality of Life, Vascular Endothelial Growth Factor A
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.
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).
Interventions
BEHAVIORALAerobic 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)
BEHAVIORALPhysiological 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).
Sponsors
Universitas Padjadjaran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Endothelial Growth Factor (VEGF) Level | 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
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 (IL-6) Level | 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. |
| Interleukin-10 (IL-10) Level | 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. |
| 6-Minute Walk Distance (6-MWD) | 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. |
| Muscle Strength (Maximum Voluntary Contraction, MVC) | 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. |
| Quality of Life (36-Item Short Form Health Survey, SF-36) | 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. |
Countries
Indonesia
Outcome results
None listed