- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824805
Hypertension, Ethnicity and Exercise Trial (HYPE2X)
February 10, 2025 updated by: Véronique Cornelissen, KU Leuven
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 Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paramaribo, Suriname
- Anton De Kom University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: isometric handgrip exercise
4x2 minutes of isometric handgrip exercise
|
aerobic exercise for 30 minutes at 40-60% HRres
|
|
No Intervention: control
seated control session
|
|
|
Experimental: Aerobic exercise
aerobic exercise at 40-60% HRres
|
aerobic exercise for 30 minutes at 40-60% HRres
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
office blood pressure at 30 minutes post exercise
Time Frame: 30 minutes postexercsie
|
office blood pressure at 30 minutes post exercise
|
30 minutes postexercsie
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
daytime blood pressure
Time Frame: mean of 8 hours after the intervention
|
daytime ambulatory blood pressure (8 hours after the intervention)
|
mean of 8 hours after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
February 10, 2025
First Submitted That Met QC Criteria
February 10, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 183/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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