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Heart FailureEXIT-HFNCT04334603

EXercise InTervention in Heart Failure

A study testing Exercise Training Program in people with Heart Failure, run by Centro Hospitalar do Porto at 1 site 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

This is a pragmatic, non-inferiority clinical trial, enrolling heart failure patients who will be randomized to a 12-week exercise training program either centre-based or home-based with telemonitoring. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Exercise Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 sitePortugal
Study dates
1 Nov 2019to 30 Dec 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of HFrEF and HFpEF according to criteria of the European Society of Cardiology (2016)
  • Clinical stability for ≥ 6 weeks
  • Optimal medical treatment for ≥ 6 weeks
  • Patients that are able to understand and follow the exercise prescription
  • Written informed consent

Who cannot join

  • Patients who have undertaken cardiac rehabilitation within the past 12 months
  • Patients who have received an intracardiac defibrillator (ICD), Cardiac 3. Resynchronisation therapy (CRT) or combined CRT/ICD device implanted in the last 6 weeks
  • Inability to exercise or conditions that may interfere with exercise intervention
  • Signs of ischemia during cardiopulmonary exercise test
  • Comorbidity that may influence one-year prognosis
  • Symptomatic and/or exercise induced cardiac arrhythmia or conduction disturbances
Show all 10Show fewer
  • Currently pregnant or intend to become pregnant in the next year
  • Expectation of receiving a cardiac transplant in the next 6 months
  • Participation in another clinical trial
  • Patients who are unable to understand the study information or unable to complete the outcome questionnaires

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Centro Hospitalar do Porto

    Porto, 4099-001

Other trials in Portugal

About this study

Official title: EXercise InTervention in Heart Failure (EXIT-HF): a Randomized Controlled Trial

This is a pragmatic, non-inferiority clinical trial, enrolling heart failure patients who will be randomized to a 12-week exercise training program either centre-based or home-based with telemonitoring. The impact of this intervention will be assessed on established surrogate markers in HF such as maximal exercise capacity, plasma biomarkers and quality of life. The cost-effectiveness and overall satisfaction with the treatment will also be studied. In addition to measure the clinical and economic impact of this innovative way of delivering exercise, it is intended to unravel new molecular pathways and assess a pool of biomarkers that provide a wide mechanistic picture underlying the clinical effects of exercise.

Conditions
Heart Failure
Being tested
Exercise Training Program
Keywords
Heart failure, Home-based exercise, Maximal oxygen consumption, Cost-effectiveness
Medical subject headings
Heart Failure

What participants receive

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

  • Exercise Training ProgramOther

    The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital or at home.

Study groups in NCT04334603
Study groupRoleWhat they receive
Home-based exercise trainingExperimentalThe 12-week exercise-training program will include two sessions of combined exercise training per week, performed at home
Receives: Other: Exercise Training Program
Clinical-based exercise trainingActive comparatorThe 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital
Receives: Other: Exercise Training Program

What is being measured

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

  1. Peak oxygen uptake (ml/kg/min)

    Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 3 moths

    Measured: Change from baseline in peak oxygen uptake (ml/kg/min) at 3 months

Secondary outcomes (17)

  1. 6-min walk test (6MWT) distance

    Changes in distance from the 6MWT.

    Measured: Change from baseline to 3 months, and to 12 months.

  2. Health status (EQ-5D-5L)

    Health status will be evaluated by the 5-level EQ-5D version (EQ-5D-5L) questionnaire. The questionnaire comprises five dimensions, each describing a different aspect of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has five response levels of severity which range from 0 (no problems) to 5 (extreme problems/ unable to do). In addition, there is a score of overall health range from 0 to 100%.

    Measured: Change from baseline to 3 months, and to 12 months.

  3. Health-related quality of life (MLHFQ)

    Health-related quality of life will be evaluated by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is composed of 21 questions rated on a scale from 0 (no effect) to 5 (very much). The questionnaire is scored by summation of all 21 responses, where higher scores indicate worse quality of life.

    Measured: Change from baseline to 3 months, and to 12 months.

  4. Anxiety and Depression (HADS)

    Anxiety and Depression will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire is composed of 14 questions on a four-point (0-3) scale. The possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. A score of 0 to 7 for either subscale will be regarded as being in the normal range, a score of 11 or higher indicating probable presence of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.

    Measured: Change from baseline to 3 months, and to 12 months.

  5. Disutility

    Individual disutility (inconvenience) perceived by patients and respective quality of life gains. Longevity to offset the exercise program disutility will be expressed in days.

    Measured: Evaluate at 3th month

  6. Physical activity (steps/day)

    Physical activity will be assessed by a POLAR-M200 device with the numbers of daily steps.

    Measured: Change from baseline to 3 months, and to 12 months.

  7. Daily physical activity levels (min/day)

    Daily physical activity levels it will be measure with a POLAR-M200 device. Measures will be described as time spend in light physical activity, moderate and vigorous physical activity, and spend sitting or lying (minutes per day).

    Measured: Change from baseline to 3 months, and to 12 months.

  8. Dyspnea

    Dyspnea will be evaluated by the Dyspnea-12 (D-12) questionnaire. The D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items. Total scores from the D-12 range from 0 to 36, with higher scores corresponding to greater severity.

    Measured: Change from baseline to 3 months, and to 12 months.

  9. Mediterranean diet

    Adherence to Mediterranean diet will be evaluated by the 14-Item Mediterranean Diet Assessment Tool (MEDAS-14). The answer to each of the 14 items is scored with 1 in the case of meeting the criteria defined as typical of this type of food (range of possible variation 0-14 points). A total score ≥10 as represent a good adherence to the Mediterranean diet.

    Measured: Change from baseline to 3 months, and to 12 months.

  10. Hand grip strength

    Hand grip strength will be assessed by Jamar dynamometer (kg)

    Measured: Change from baseline to to 3 and to 12 months.

  11. 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

  12. Biomarkers (pg/ml)

    NTproBNP and ST2 (pg/ml)

    Measured: Change from baseline to 3 months

  13. Biomarkers (mg/L)

    hsCRP and Troponin (mg/L)

    Measured: Change from baseline to 3 months

  14. Concentration of plasma exosomes

    Plasma exosomes will be isolated using microbead-based sorting techniques and characterized by nanoparticle tracking analysis, Western blot, and quantitative real-time polymerase chain reaction assessments

    Measured: Change from baseline to 3 months

  15. Percentage of protein aggregates

    Protein aggregates (%) will be analysed using a diagonal two-dimensional (D2D) SDS-PAGE assay with mass spectrometry to identify and characterize detergent-resistant protein aggregates in plasma pre-cleared from albumin and immunoglobulin.

    Measured: Change from baseline to 3 months

  16. Cost-effectiveness of home-based exercise Vs. clinical-base exercise

    Compare cost effectiveness analysis of home-based exercise Vs. clinical-base exercise. The main outcome measure for this study will be cost per quality adjusted life year (QALY)

    Measured: At 12th month

  17. Physical fitness levels evaluation

    Physical fitness levels will be evaluated by the Senior Fitness test

    Measured: Change from baseline to 3 and to 12 months.

Timeline

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

  1. First posted6 Apr 2020
  2. Study start1 Nov 2019
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334603
Sponsor's protocol ID
2019.123
Acronym
EXIT-HF
Status last verified
Feb 2023
First submitted
22 Jan 2020
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schmidt C, Magalhaes S, Gois Basilio P, Santos C, Oliveira MI, Ferreira JP, Ribeiro F, Santos M. Center- vs Home-Based Cardiac Rehabilitation in Patients With Heart Failure: EXIT-HF Randomized Controlled Trial. JACC Heart Fail. 2025 May;13(5):695-706. doi: 10.1016/j.jchf.2024.09.024. Epub 2025 Jan 29.

    PubMed 39895436

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Training Program in people with Heart Failure, run by Centro Hospitalar do Porto at 1 site 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 5 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Peak oxygen uptake (ml/kg/min) (time frame: Change from baseline in peak oxygen uptake (ml/kg/min) 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 NCT04334603, which also lists 1 linked publication.

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 23 Feb 2023.

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