NCT03090529

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

March 13, 2017

Last Update Submit

December 16, 2020

Conditions

Resistant Hypertension

Keywords

Exercise trainingAmbulatory blood pressureResistant HypertensionNitric Oxide

Outcome Measures

Primary Outcomes (1)

  • Ambulatory blood pressure

    Blood pressure

    Change from Baseline in Blood Pressure at 3 months

Secondary Outcomes (11)

  • Casual blood pressure

    Change from baseline to 3 months

  • Body composition

    Change from baseline to 3 months

  • Health-related quality of life

    Change from baseline to 3 months

  • Arterial stiffness

    Change from baseline to 3 months

  • Heart rate variability

    Change from baseline to 3 months

  • +6 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Other: Exercise Group

Control group

NO INTERVENTION

The control group will receive usual medical care

Interventions

Exercise GroupOTHER

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

Exercise group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with secondary hypertension
  • Evidence of target organ damage
  • Patients with heart failure
  • Previous cardiovascular event
  • Peripheral artery disease
  • Renal failure
  • Chronic obstructive pulmonary disease
  • Systolic office blood pressure superior to 180 mmHg
  • Biomechanical limitations to physical activity
  • Those participating in regular physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Aveiro, 3800, Portugal

Location

Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos

Matosinhos Municipality, 4464-513, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 34347008DERIVED

Study Officials

  • José Mesquita Bastos, MD, PhD

    Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

March 13, 2017

First Posted

March 24, 2017

Study Start

March 30, 2017

Primary Completion

December 30, 2019

Study Completion

March 30, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

PT(2)