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Aerobic Exercise and Resistant Hypertension

Primary Purpose

Resistant Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Moderate-intensity interval training (MIIT)
Moderate-intensity continuous training (MICT)
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistant Hypertension focused on measuring physical exercise, blood pressure, proteomics, resistant hypertension

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidad Europea Madrid (UEM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Moderate-intensity interval training (MIIT)

Moderate-intensity continuous training (MICT)

Usual care

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in 24-hour ambulatory blood pressure
Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours.

Secondary Outcome Measures

Change in plasma proteome
It will be used liquid chromatography coupled to tandem mass spectrometry.

Full Information

First Posted
September 21, 2022
Last Updated
October 5, 2022
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05563077
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Hypertension
Keywords
physical exercise, blood pressure, proteomics, resistant hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes Assessor
Masking Description
Care providers and outcomes assessors will be blinded to group allocation.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate-intensity interval training (MIIT)
Arm Type
Experimental
Arm Description
24 participants with resistant hypertension will perform moderate-intensity interval training.
Arm Title
Moderate-intensity continuous training (MICT)
Arm Type
Experimental
Arm Description
24 participants with resistant hypertension will perform moderate-intensity continuous training.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
24 participants with resistant hypertension will maintain usual care for 4 months.
Intervention Type
Other
Intervention Name(s)
Moderate-intensity interval training (MIIT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate-intensity continuous training (MICT)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in 24-hour ambulatory blood pressure
Description
Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours.
Time Frame
Baseline to immediate post-treatment (4 months) and after 3 months (7 months)
Secondary Outcome Measure Information:
Title
Change in plasma proteome
Description
It will be used liquid chromatography coupled to tandem mass spectrometry.
Time Frame
Baseline to immediate post-treatment (4 months)
Other Pre-specified Outcome Measures:
Title
Change in flow-mediated dilation
Description
Ultrasound imaging of the brachial artery will be performed.
Time Frame
Baseline to immediate post-treatment (4 months)
Title
Change in aerobic capacity
Description
VO2 will be measured breath-by-breath using a gas exchange analysis system.
Time Frame
Baseline to immediate post-treatment (4 months)
Title
Change in body composition
Description
Dual-energy X-ray absorptiometry (DXA) scans will performed to measure body composition (fat mass and lean mass).
Time Frame
Baseline to immediate post-treatment (4 months)
Title
Change in lipid profiles
Description
Blood analysis will be performed to evaluate HDL-C, LDL-C, total cholesterol, and triglyceride levels.
Time Frame
Baseline to immediate post-treatment (4 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Gómez Valea
Phone
+34917407272
Email
roberto.gomez@universidadeuropea.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Ruilope, PhD
Organizational Affiliation
UEM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Europea Madrid (UEM)
City
Madrid
ZIP/Postal Code
28670
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OTRI
Phone
+34917407272
First Name & Middle Initial & Last Name & Degree
Luis Ruilope

12. IPD Sharing Statement

Plan to Share IPD
No

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Aerobic Exercise and Resistant Hypertension

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