Aerobic Exercise and Resistant Hypertension

Resistant Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563077
• Other study ID #: UEM
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: August 2025

Study information

• Verified date: October 2022
• Source: Universidad Europea de Madrid
• Contact: Roberto Gómez Valea
• Phone: +34917407272
• Email: roberto.gomez[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad Europea Madrid (UEM)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in flow-mediated dilation	Ultrasound imaging of the brachial artery will be performed.	Baseline to immediate post-treatment (4 months)
Other	Change in aerobic capacity	VO2 will be measured breath-by-breath using a gas exchange analysis system.	Baseline to immediate post-treatment (4 months)
Other	Change in body composition	Dual-energy X-ray absorptiometry (DXA) scans will performed to measure body composition (fat mass and lean mass).	Baseline to immediate post-treatment (4 months)
Other	Change in lipid profiles	Blood analysis will be performed to evaluate HDL-C, LDL-C, total cholesterol, and triglyceride levels.	Baseline to immediate post-treatment (4 months).
Primary	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	Change in plasma proteome	It will be used liquid chromatography coupled to tandem mass spectrometry.	Baseline to immediate post-treatment (4 months)