Hypertension, Ethnicity and Exercise Trial
HYPE2X
1 other identifier
interventional
60
1 country
1
Brief 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 hypertension of South-Asian or African descent living in Suriname.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Jun 2020
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedFirst Submitted
Initial submission to the registry
February 10, 2025
CompletedFirst Posted
Study publicly available on registry
February 13, 2025
CompletedFebruary 13, 2025
February 1, 2025
3.5 years
February 10, 2025
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
office blood pressure at 30 minutes post exercise
office blood pressure at 30 minutes post exercise
30 minutes postexercsie
Secondary Outcomes (1)
daytime blood pressure
mean of 8 hours after the intervention
Study Arms (3)
isometric handgrip exercise
ACTIVE COMPARATOR4x2 minutes of isometric handgrip exercise
control
NO INTERVENTIONseated control session
Aerobic exercise
EXPERIMENTALaerobic exercise at 40-60% HRres
Interventions
aerobic exercise for 30 minutes at 40-60% HRres
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
Anton De Kom University
Paramaribo, Suriname
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2025
First Posted
February 13, 2025
Study Start
June 1, 2020
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
February 13, 2025
Record last verified: 2025-02