Aerobic Exercise and Resistant Hypertension

Last updated: October 5, 2022
Sponsor: Universidad Europea de Madrid
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Vascular Diseases

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT05563077
UEM
  • Ages 30-70
  • All Genders

Study Summary

This study will examine the effects of 4 months of aerobic interval training versus continuous aerobic training on ambulatory blood pressure (ABP) and novel plasma protein biomarkers in patients with resistant hypertension. In addition, we will measure ABP after a training cessation period of 3 months (i.e., 7 months follow-up). A randomized controlled trial will be performed including two exercise groups and a control group: a) moderate-intensity interval training (MIIT); b) moderate-intensity continuous training (MICT); c) usual care. MIIT could represent a superior training modality that exceeds the benefits of MICT in patients with resistant hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with resistant hypertension (RH) (i.e., systolic BP/diastolic BP >130/80 mmHgaccording to the American College of Cardiology/American Heart Association) despitethe concurrent use of three or more antihypertensive drugs - commonly including adiuretic, a long-acting calcium channel blocker, and a blocker of therenin-angiotensin system. RH also includes patients whose BP achieves target values on ≥ 4 antihypertensive. medications (i.e., 'controlled' RH).
  • Adherence to prescribed medications.
  • Willing to be randomized to one of the 3 groups.
  • Informed consent.

Exclusion

Exclusion Criteria:

  • Exclusion criteria will include exercising more than 20 minutes on 3 days or moreweekly.
  • Severe ischemic heart disease, major psychiatric disorder and other healthcontraindications that may interfere in the evaluations or interventions.

Study Design

Total Participants: 72
Study Start date:
October 05, 2022
Estimated Completion Date:
August 31, 2025

Study Description

Hypertension is associated with an increased risk of cardiovascular morbidity and mortality, and its high prevalence remains a worldwide concern. Ambulatory blood pressure monitoring (ABPM) is recognized in the diagnosis and management of hypertension, and can control blood pressure better than clinic assessment. Different studies have examined the effects of aerobic training on ABP in patients with hypertension, but the effects of moderate-intensity interval training (MIIT) and moderate-intensity continuous training (MICT) on ABP and novel plasma protein biomarkers that could potentially serve to identify cardiovascular risk, have not yet been examined in patients with resistant hypertension.To fill this gap, our aims are to determine the effects of MIIT and MICT for 4 months on ABP (primary endpoint), and on proteomic biomarkers (secondary endpoints) in patients with resistant hypertension. In addition, we will measure ABP after a training cessation period of 3 months (i.e., 7 months follow-up). A total of 72 participants will be randomly divided into three groups: the first group (n=24) will perform MIIT, the second group (n=24) will perform MICT, and the third control group (n=24) will maintain usual care for 4 months. All will receive usual care for 7 months, with the structured physical exercise as the only relevant change in the intervention groups.

Connect with a study center

  • Universidad Europea Madrid (UEM)

    Madrid, 28670
    Spain

    Active - Recruiting

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