Primary Hypertension, Grade 2NCT07375407
Aerobic Exercise vs Physiological Ischemic Training in Stage 2 Hypertension
A study testing Aerobic Exercise (AE) and Physiological Ischemic Training (PIT) in people with Primary Hypertension, Grade 2, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Hypertension, Grade 2
- What is being tested?
- Aerobic Exercise (AE) and Physiological Ischemic Training (PIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Aug 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hypertension patients aged 18-65 years
- Diagnosed with grade 2 primary hypertension
- Willing to participate in the study
Who cannot join
- Patients with unstable angina
- Malignant arrhythmias and high atrioventricular block
- Unstable hemodynamics
- Uncontrolled hypertension
- Acute pericarditis
- Severe valvular heart disease
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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).
- Conditions
- Primary Hypertension, Grade 2
- Being tested
- Aerobic Exercise (AE), Physiological Ischemic Training (PIT)
- Keywords
- Cardiorespiratory Fitness, Interleukin-6, Interleukin-10, Quality of Life, Vascular Endothelial Growth Factor A
- Medical subject headings
- Essential Hypertension, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise (AE)Behavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Physiological Ischemic Training (PIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and after 6 weeks of intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start5 Aug 2023
- Primary completion5 Dec 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hypertension, Grade 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnengsih Nazir, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375407
- Sponsor's protocol ID
- IKFR-202502.02
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07375407
- Acronym / sponsor ID
- IKFR-202502.02
- Conditions
- Primary Hypertension, Grade 2
- Keywords
- Cardiorespiratory Fitness, Interleukin-6, Interleukin-10, Quality of Life, Vascular Endothelial Growth Factor A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise (AE) | Experimental | Behavioral: 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). |
| Physiological Ischemic Training (PIT) | Experimental | Behavioral: 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary hypertension patients aged 18-65 years
- Diagnosed with grade 2 primary hypertension
- Willing to participate in the study
Key exclusion criteria (16 listed)
- Patients with unstable angina
- Malignant arrhythmias and high atrioventricular block
- Unstable hemodynamics
- Uncontrolled hypertension
- Acute pericarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Aerobic Exercise (AE) |
| 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). | Behavioural | Physiological Ischemic Training (PIT) |
Primary outcome
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.
5 secondary outcomes
Interleukin-6 (IL-6) Level
Time frame: Baseline and 6 weeks
Interleukin-10 (IL-10) Level
Time frame: Baseline and 6 weeks
6-Minute Walk Distance (6-MWD)
Time frame: Baseline and 6 weeks
Muscle Strength (Maximum Voluntary Contraction, MVC)
Time frame: Baseline and 6 weeks
Quality of Life (36-Item Short Form Health Survey, SF-36)
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise (AE) and Physiological Ischemic Training (PIT) in people with Primary Hypertension, Grade 2, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Endothelial Growth Factor (VEGF) Level (time frame: Measured at baseline and after 6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.