Hypertension, Ethnicity and Exercise Trial | NCT06824805

Studies
Hypertension, Ethnicity and Exercise Trial

NCT06824805

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Feb 13, 2025Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Exercise

Countries

Suriname

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Nov 30, 2023Actual

Completion Date

Nov 30, 2023Actual

First Submitted Date

Feb 10, 2025

First Submission Date that Met QC Criteria

Feb 10, 2025

First Posted Date

Feb 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
isometric handgrip exercise	Active Comparator	4x2 minutes of isometric handgrip exercise	Behavioral: Exercise
control	No Intervention	seated control session
Aerobic exercise	Experimental	aerobic exercise at 40-60% HRres	Behavioral: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	aerobic exercise for 30 minutes at 40-60% HRres	Aerobic exercise isometric handgrip exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
office blood pressure at 30 minutes post exercise	office blood pressure at 30 minutes post exercise	30 minutes postexercsie

Secondary Outcomes

Measure	Description	Time Frame
daytime blood pressure	daytime ambulatory blood pressure (8 hours after the intervention)	mean of 8 hours after the intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided