Clinical trial NCT05563077: Aerobic Exercise and Resistant Hypertension
Official title: Effects of Two Types of Aerobic Training on Ambulatory Blood Pressure in Hypertensives: a Systems Biology Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Resistant Hypertension
Keywords: physical exercise
blood pressure
proteomics
resistant hypertension
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample of this study will be randomized in a 1:1:1 ratio (www.randomizer.org) based on a computer-generated random allocation sequence, and will be concealed using sequentially numbered, opaque, sealed envelopes to MIIT, MICT and control groups.
Primary purpose: TREATMENT

Brief 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. 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.

Detailed 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. 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 4 months, with the structured physical exercise as the only relevant change in the intervention groups.

Eligibility criteria: 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 30 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.

Primary outcomes:
measure: Change in 24-hour ambulatory blood pressure
timeFrame: Baseline to immediate post-treatment (4 months)
Secondary outcomes:
measure: Change in plasma proteome
timeFrame: Baseline to immediate post-treatment (4 months)
measure: Changes in albuminuria
timeFrame: Baseline to immediate post-treatment (4 months)
measure: Changes in glomerular filtration rate
timeFrame: Baseline to immediate post-treatment (4 months)
Other outcomes:
measure: Change in aerobic capacity
timeFrame: Baseline to immediate post-treatment (4 months)
measure: Change in body composition
timeFrame: Baseline to immediate post-treatment (4 months)
measure: Change in lipid profiles
timeFrame: Baseline to immediate post-treatment (4 months).
Locations:
city: Madrid
country: Spain
facility: Universidad Europea Madrid (UEM)
Study officials:
affiliation: UEM
name: Luis Ruilope, PhD
role: PRINCIPAL_INVESTIGATOR
References: