EXercise InTervention in Heart Failure

NCT04334603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-02-23

No results posted yet for this study

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

Interventions

OTHER

Exercise Training Program

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

Sponsors & Collaborators

  • Universidade do Porto

    collaborator OTHER
  • Aveiro University

    collaborator OTHER
  • Centro Hospitalar do Porto

    lead OTHER

Principal Investigators

  • Mário Santos, MD,PhD · Cardiology Service of Centro Hospitalar do Porto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Portugal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334603 on ClinicalTrials.gov