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

Status

Completed

Conditions

Intervention / Treatment

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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