Aerobic Exercise and Resistant Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Two Types of Aerobic Training on Ambulatory Blood Pressure in Hypertensives: a Systems Biology Approach

Conditions
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Resistant Hypertension

Intervention / Treatment
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* Other: Moderate-intensity interval training (MIIT)
* Other: Moderate-intensity continuous training (MICT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate-intensity interval training (MIIT)<br>24 participants with resistant hypertension will perform moderate-intensity interval training. | Other: Moderate-intensity interval training (MIIT)<br>* MIIT group: participants will perform 3 sessions per week for 4 months. Each session will involve a ∼3 min warm-up (joint mobility exercises and walking at ∼2.2 METs), a ∼40-50 min main period (∼6-7 reps of 4 min at ∼4.2 METs, with 3 min of active recovery at ∼2.2 METs between each interval), and a ∼3-min cool-down (joint mobility exercises and walking at ∼2.2 METs). We will select the same aerobic dose of training (i.e., kcal/kg of body weight per week) to match total energy expenditure in both exercise groups.<br>|
| Experimental: Moderate-intensity continuous training (MICT)<br>24 participants with resistant hypertension will perform moderate-intensity continuous training. | Other: Moderate-intensity continuous training (MICT)<br>* MICT group: participants will perform 3 sessions per week for 4 months. Each session will involve a ∼3 min warm-up (joint mobility exercises and walking at ∼2.2 METs), a ∼40-50 min main period at ∼3.2 METs, and a ∼3-min cool-down (joint mobility exercises and walking at ∼2.2 METs).<br>|
| No Intervention: Usual care<br>24 participants with resistant hypertension will maintain usual care for 4 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour ambulatory blood pressure | Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours. | Baseline to immediate post-treatment (4 months) and after 3 months (7 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma proteome | It will be used liquid chromatography coupled to tandem mass spectrometry. | Baseline to immediate post-treatment (4 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical exercise, blood pressure, proteomics, resistant hypertension