Aerobic Exercise and Resistant Hypertension

NCT05563077 | Active Not Recruiting DMC

• 1 other identifier: UEM
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistant Hypertension

Keywords

physical exercise; blood pressure; proteomics; resistant hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Change in plasma proteome

  Baseline to immediate post-treatment (4 months)

• Changes in albuminuria

  Baseline to immediate post-treatment (4 months)

• Changes in glomerular filtration rate

  Baseline to immediate post-treatment (4 months)

Other Outcomes (15)

• Change in aerobic capacity

  Baseline to immediate post-treatment (4 months).

• Change in body composition

  Baseline to immediate post-treatment (4 months)

• Change in lipid profiles

  Baseline to immediate post-treatment (4 months).

Study Arms (3)

Moderate-intensity interval training (MIIT)

EXPERIMENTAL

24 participants with resistant hypertension will perform moderate-intensity interval training.

Other: Moderate-intensity interval training (MIIT)

Moderate-intensity continuous training (MICT)

EXPERIMENTAL

24 participants with resistant hypertension will perform moderate-intensity continuous training.

Other: Moderate-intensity continuous training (MICT)

Usual care

NO INTERVENTION

24 participants with resistant hypertension will maintain usual care for 4 months.

Interventions

Moderate-intensity interval training (MIIT) OTHER

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 interval training (MIIT)

Moderate-intensity continuous training (MICT) OTHER

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).

Moderate-intensity continuous training (MICT)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe ischemic heart disease, major psychiatric disorder and other health contraindications that may interfere in the evaluations or interventions.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Universidad Europea Madrid (UEM)

Madrid, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Luis Ruilope, PhD

  UEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care providers and outcomes assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 3, 2022
• Study Start: October 5, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 15, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)