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Resistant HypertensionEnRIcHNCT03090529

The Role of Exercise Training in the Treatment of Resistant Hypertension

A study testing Exercise Group in people with Resistant Hypertension, run by Aveiro University at 2 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Resistant Hypertension
What is being tested?
Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesPortugal
Study dates
30 Mar 2017to 30 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients with secondary hypertension
  • Evidence of target organ damage
  • Patients with heart failure
  • Previous cardiovascular event
  • Peripheral artery disease
  • Renal failure
Show all 10Show fewer
  • Chronic obstructive pulmonary disease
  • Systolic office blood pressure superior to 180 mmHg
  • Biomechanical limitations to physical activity
  • Those participating in regular physical activity

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

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

    Aveiro, 3800

  • Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos

    Matosinhos Municipality, 4464-513

Other trials in Portugal

About this study

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.

Being tested
Exercise Group
Keywords
Exercise training, Ambulatory blood pressure, Resistant Hypertension, Nitric Oxide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise GroupOther

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

Study groups in NCT03090529
Study groupRoleWhat they receive
Exercise groupExperimentalThe 12-week exercise-training program will include three sessions of aerobic exercise per week
Receives: Other: Exercise Group
Control groupNo interventionThe control group will receive usual medical care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ambulatory blood pressure

    Blood pressure

    Measured: Change from Baseline in Blood Pressure at 3 months

Secondary outcomes (11)

  1. Casual blood pressure

    Blood pressure

    Measured: Change from baseline to 3 months

  2. Body composition

    Body composition

    Measured: Change from baseline to 3 months

  3. Health-related quality of life

    Health-related quality of life will be evaluated by the Short-Form 36.

    Measured: Change from baseline to 3 months

  4. Arterial stiffness

    Carotid-femoral pulse wave velocity, central pressures and aortic augmentation index and augmentation pressure.

    Measured: Change from baseline to 3 months

  5. Heart rate variability

    Recordings of R-R interval data; The R-R interval will be analyzed using time domain, frequency domain and Poincare´ plot techniques.

    Measured: Change from baseline to 3 months

  6. Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase

    These markers will inform endothelial function, damage and repair

    Measured: Change from baseline to 3 months

  7. Inflammation

    Plasma levels of inflammatory and anti-inflammatory biomarkers.

    Measured: Change from baseline to 3 months

  8. Oxidative stress

    Plasma levels of oxidative stress and antioxidant markers.

    Measured: Change from baseline to 3 months

  9. Daily physical activity

    Physical activity will be measured during 7 consecutive days using an accelerometer.

    Measured: Change from baseline to 3 months

  10. Dietary intake

    Dietary intake will be assessed using a 4-day food diary.

    Measured: Change from baseline to 3 months

  11. VO2 max

    VO2 max will be determined by the Chester step test.

    Measured: Change from baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start30 Mar 2017
  3. Primary completion30 Dec 2019
  4. Study completion30 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03090529
Sponsor's protocol ID
1725/2014
Acronym
EnRIcH
Status last verified
Dec 2020
First submitted
13 Mar 2017
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lopes S, Diniz F, Mesquita Bastos J, Oliveira J, Polonia J, Alves AJ, Ribeiro F, Figueiredo D. "What do we think?": a qualitative exploratory study of acceptability and experiences of individuals with resistant hypertension after completing a physical exercise program (the EnRICH trial). Disabil Rehabil. 2024 Jun;46(12):2662-2669. doi: 10.1080/09638288.2023.2229237. Epub 2023 Jul 9.

    PubMed 37424233

  • 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.

    PubMed 34347008

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Group in people with Resistant Hypertension, run by Aveiro University at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulatory blood pressure (time frame: Change from Baseline in Blood Pressure at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03090529, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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