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Completed

NCT Number: NCT04334603

EXercise InTervention in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Exercise training program

Other

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

Primary outcomes

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

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

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

Secondary outcomes

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

    Time frame: Change from baseline to 3 months, and to 12 months.

    Changes in distance from the 6MWT.

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

    Time frame: Change from baseline to 3 months, and to 12 months.

    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%.

  3. Health-related quality of life (MLHFQ)

    Time frame: Change from baseline to 3 months, and to 12 months.

    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.

  4. Anxiety and Depression (HADS)

    Time frame: Change from baseline to 3 months, and to 12 months.

    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.

  5. Disutility

    Time frame: Evaluate at 3th month

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

  6. Physical activity (steps/day)

    Time frame: Change from baseline to 3 months, and to 12 months.

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

  7. Daily physical activity levels (min/day)

    Time frame: Change from baseline to 3 months, and to 12 months.

    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).

  8. Dyspnea

    Time frame: Change from baseline to 3 months, and to 12 months.

    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.

  9. Mediterranean diet

    Time frame: Change from baseline to 3 months, and to 12 months.

    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.

  10. Hand grip strength

    Time frame: Change from baseline to to 3 and to 12 months.

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

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

    Time frame: Change from baseline to 3 months

    These markers will inform endothelial function, damage and repair

  12. Biomarkers (pg/ml)

    Time frame: Change from baseline to 3 months

    NTproBNP and ST2 (pg/ml)

  13. Biomarkers (mg/L)

    Time frame: Change from baseline to 3 months

    hsCRP and Troponin (mg/L)

  14. Concentration of plasma exosomes

    Time frame: Change from baseline to 3 months

    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

  15. Percentage of protein aggregates

    Time frame: Change from baseline to 3 months

    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.

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

    Time frame: At 12th month

    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)

  17. Physical fitness levels evaluation

    Time frame: Change from baseline to 3 and to 12 months.

    Physical fitness levels will be evaluated by the Senior Fitness test

Other outcomes

  1. Exploratory analyses of urine proteome

    Time frame: Change from baseline to 3 months

    Exploratory analyses in urine protein will be performed to identify novel biomarkers predictive of exercise training therapeutic response. Urine of 10 patients from each group will be analyzed using a proteomic approach combining one-dimensional gel electrophoresis with liquid chromatography-tandem mass spectrometry (GeLC-MS/MS). Generated proteomic data will be analyzed with bioinformatic tools to reveal possible biomarkers of interest, that will be further validated by immuno-approaches such as ELISA or immunoblot.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Porto

Other

Collaborators

  • Aveiro University
  • Universidade do Porto

Registry information

Official study title

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

Acronym: EXIT-HF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2020
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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