HypertensionHYPE2XNCT06824805
Hypertension, Ethnicity and Exercise Trial
A study testing Exercise in people with Hypertension, run by KU Leuven at 1 site in Suriname.
Trial summary
The main aim of this study is to investigate the acute effects of a single bout of isometric handgrip exercise (IHG) and a single bout of aerobic endurance exercise (AEX) on blood pressure, both immediately after exercise and during the subsequent activities of daily living in patients with high-normal to grade 1… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Exercise
- 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 siteSuriname
- Study dates
- 1 Jun 2020to 30 Nov 2023
- 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
- • Age 18 - 65 years
- Patients with high- normal BP (SBP: 130 - 139 mmHg or and DBP: 85 - 89 mmHg) or stage I hypertension (SBP: 140 - 159 mmHg or DBP: 90 - 99 mmHg) according to the ESC/ESH guidelines [15]
- Asian or African descent
- Do not meet the level of physical activity recommended by the WHO based on self-report [15]
- Non-medicated patients or patients using a maximum of 2 antihypertensive drugs
Who cannot join
- • Functional or mental limitation limiting the correct execution of an exercise bout
- History of ischemic stroke, autonomic neuropathy, cardiovascular, renal, or pulmonary disease by self-report
- Diabetes type I or II
- Pregnancy
- The presence of exercise induced signs of myocardial ischemia or complex ventricular arrhythmia during CPET
- Patients using three or more antihypertensive drugs or patients with resistant hypertension
Trial locations and contacts
1 site in 1 country.
Suriname1 site
Anton De Kom University
Paramaribo
About this study
The main aim of this study is to investigate the acute effects of a single bout of isometric handgrip exercise (IHG) and a single bout of aerobic endurance exercise (AEX) on blood pressure, both immediately after exercise and during the subsequent activities of daily living in patients with high-normal to grade 1 hypertension of South-Asian or African descent living in Suriname.
- Conditions
- Hypertension
- Being tested
- Exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
aerobic exercise for 30 minutes at 40-60% HRres
| Study group | Role | What they receive |
|---|---|---|
| isometric handgrip exercise | Active comparator | 4x2 minutes of isometric handgrip exercise Receives: Behavioral: Exercise |
| control | No intervention | seated control session |
| Aerobic exercise | Experimental | aerobic exercise at 40-60% HRres Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
office blood pressure at 30 minutes post exercise
office blood pressure at 30 minutes post exercise
Measured: 30 minutes postexercsie
Secondary outcomes (1)
daytime blood pressure
daytime ambulatory blood pressure (8 hours after the intervention)
Measured: mean of 8 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Jun 2020
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Véronique Cornelissen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824805
- Sponsor's protocol ID
- 183/2020
- Acronym
- HYPE2X
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension, Ethnicity and Exercise Trial
- ClinicalTrials.gov ID
- NCT06824805
- Acronym / sponsor ID
- HYPE2X / 183/2020
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 13 Feb 2025 (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.
The main aim of this study is to investigate the acute effects of a single bout of isometric handgrip exercise (IHG) and a single bout of aerobic endurance exercise (AEX) on blood pressure, both immediately after exercise and during the subsequent activities of daily living in patients with high-normal to grade 1 hypertension of South-Asian or African descent living in Suriname.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| isometric handgrip exercise | Active comparator | Behavioral: Exercise4x2 minutes of isometric handgrip exercise |
| control | No intervention | –seated control session |
| Aerobic exercise | Experimental | Behavioral: Exerciseaerobic exercise at 40-60% HRres |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Age 18 - 65 years
Key exclusion criteria (6 listed)
- • Functional or mental limitation limiting the correct execution of an exercise bout
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 |
|---|---|---|
| Exerciseaerobic exercise for 30 minutes at 40-60% HRres | Behavioural | Aerobic exercise, isometric handgrip exercise |
Primary outcome
office blood pressure at 30 minutes post exercise
Time frame: 30 minutes postexercsie
office blood pressure at 30 minutes post exercise
1 secondary outcome
daytime blood pressure
Time frame: mean of 8 hours after the intervention
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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 Exercise in people with Hypertension, run by KU Leuven at 1 site in Suriname.
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 5 inclusion and 6 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 13 Feb 2025. 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 Suriname. 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?
office blood pressure at 30 minutes post exercise (time frame: 30 minutes postexercsie). 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 13 Feb 2025.