EXercise InTervention in Heart Failure

NCT04334603 | Completed

• 1 other identifier: 2019.123
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Heart failure; Home-based exercise; Maximal oxygen consumption; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake (ml/kg/min)

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

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

Secondary Outcomes (17)

• 6-min walk test (6MWT) distance

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

• Health status (EQ-5D-5L)

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

• Health-related quality of life (MLHFQ)

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

• Anxiety and Depression (HADS)

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

• Disutility

  Evaluate at 3th month

Other Outcomes (1)

• Exploratory analyses of urine proteome

  Change from baseline to 3 months

Study Arms (2)

Home-based exercise training

EXPERIMENTAL

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

Other: Exercise Training Program

Clinical-based exercise training

ACTIVE COMPARATOR

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

Other: Exercise Training Program

Interventions

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.

Clinical-based exercise training; Home-based exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead
• Universidade do Porto: collaborator
• Aveiro University: collaborator

Study Sites (1)

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Related Publications (1)

• 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.

  PMID: 39895436 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mário Santos, MD,PhD

  Cardiology Service of Centro Hospitalar do Porto

  PRINCIPAL INVESTIGATOR

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: Cardiologist, MD, PhD

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: April 6, 2020
• Study Start: November 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)