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The Role of Exercise Training in the Treatment of Resistant Hypertension

NCT ID: NCT03090529

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2020-03-30

Brief Summary

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The main purpose of this study is to assess whether exercise training reduces ambulatory blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients with resistant hypertension will be recruited and randomized into exercise training or control groups and followed up for 6 months. The patients in the exercise group will participate in a 3-month outpatient program. The control group will receive usual medical care. At baseline, after the intervention and 3 months after the end of the intervention both groups will undergo several evaluations, including casual and ambulatory blood pressure, body composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic function, and endothelial and inflammatory biomarkers.

Detailed Description

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Conditions

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Resistant Hypertension

Keywords

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Exercise training Ambulatory blood pressure Resistant Hypertension Nitric Oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise group

The 12-week exercise-training program will include three sessions of aerobic exercise per week

Group Type EXPERIMENTAL

Exercise Group

Intervention Type OTHER

The 12-week exercise-training program will include three sessions of aerobic exercise per week

Control group

The control group will receive usual medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Group

The 12-week exercise-training program will include three sessions of aerobic exercise per week

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

1. Patients with secondary hypertension
2. Evidence of target organ damage
3. Patients with heart failure
4. Previous cardiovascular event
5. Peripheral artery disease
6. Renal failure
7. Chronic obstructive pulmonary disease
8. Systolic office blood pressure superior to 180 mmHg
9. Biomechanical limitations to physical activity
10. Those participating in regular physical activity
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Institute of Maia

OTHER

Sponsor Role collaborator

Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga

UNKNOWN

Sponsor Role collaborator

Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos

UNKNOWN

Sponsor Role collaborator

Cintesis & Departamento de Medicina da Faculdade de Medicina do Porto

UNKNOWN

Sponsor Role collaborator

Aveiro University

OTHER

Sponsor Role lead

Responsible Party

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Fernando Ribeiro

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Mesquita Bastos, MD, PhD

Role: STUDY_DIRECTOR

Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga

Locations

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Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga

Aveiro, , Portugal

Site Status

Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos

Matosinhos Municipality, , Portugal

Site Status

Countries

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Portugal

References

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Lopes S, Mesquita-Bastos J, Garcia C, Bertoquini S, Ribau V, Teixeira M, Ribeiro IP, Melo JB, Oliveira J, Figueiredo D, Guimaraes GV, Pescatello LS, Polonia J, Alves AJ, Ribeiro F. Effect of Exercise Training on Ambulatory Blood Pressure Among Patients With Resistant Hypertension: A Randomized Clinical Trial. JAMA Cardiol. 2021 Nov 1;6(11):1317-1323. doi: 10.1001/jamacardio.2021.2735.

Reference Type DERIVED
PMID: 34347008 (View on PubMed)

Other Identifiers

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1725/2014

Identifier Type: -

Identifier Source: org_study_id