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Aerobic Exercise and Resistant Hypertension

E

European University

Status

Enrolling

Conditions

Resistant Hypertension

Treatments

Other: Moderate-intensity continuous training (MICT)
Other: Moderate-intensity interval training (MIIT)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with resistant hypertension (RH) (i.e., systolic BP/diastolic BP >130/80 mmHg according to the American College of Cardiology/American Heart Association) despite the concurrent use of three or more antihypertensive drugs - commonly including a diuretic, a long-acting calcium channel blocker, and a blocker of the renin-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 criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 3 patient groups

Moderate-intensity interval training (MIIT)
Experimental group
Description:
24 participants with resistant hypertension will perform moderate-intensity interval training.
Treatment:
Other: Moderate-intensity interval training (MIIT)
Moderate-intensity continuous training (MICT)
Experimental group
Description:
24 participants with resistant hypertension will perform moderate-intensity continuous training.
Treatment:
Other: Moderate-intensity continuous training (MICT)
Usual care
No Intervention group
Description:
24 participants with resistant hypertension will maintain usual care for 4 months.

Trial contacts and locations

1

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Central trial contact

Roberto Gómez Valea

Data sourced from clinicaltrials.gov

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