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NCT04848298Completed

Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure

Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure: a Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 31 May 2025

Brief summary (registry, in English)

The aim of this trial is to determine if a mobile application that promotes physical exercise in the follow-up of patients recently hospitalized with acute heart failure can improve exercise capacity after 6 months and physical activity levels compared to the standard follow-up. A randomized clinical trial will be conducted with 100 consecutive patients aged +18 years, hospitalized for acute decompensated heart failure in a tertiary referral hospital who own a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data. At discharge, patients will be randomly assigned in two groups; the intervention group will be followed with a smartphone application to promote physical activity, whereas the control group will take responsibility in their adherence to exercise recommendations. Main study variables will be functional capacity after 6 months, which will be evaluated using the six minute walking test, and physical activity levels, using the International Physical Activity Questionnaire (IPAQ). The study will be analyzed using the intention-to-treat principle. The project has been authorized by the local committee for ethics in clinical research.

Status (registry)
Completed
Study type
Interventional
Enrollment
116 (actual)
First submitted
8 Apr 2021
Start date
Apr 2021
Primary completion date
Jun 2024
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
NCT number
NCT04848298

What you commit to

  • Study type: Interventional
  • Participants enrolled: 116
  • From Apr 2021 to the primary completion date, Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ventricular arrhythmia within prior 6 months
  • ACS within prior month

Other illness

  • Currently listed for heart transplant
  • Uncontrolled arterial hypertension or resting heart rate \>100 bpm
  • Muscle-skeletal or neurologic disease preventing to perform study procedures
  • Severe lung disease
  • Moderate or severe cognitive impairment

Other

  • NYHA IV patients
  • Left ventricular assist device recipient
  • Acute myocarditis or pericarditis
  • Severe aortic stenosis
  • Hypertrophic obstructive cardiomyopathy
  • Advanced AV block
  • Unable/unwilling to consent
  • Projected life expectancy \<6 months
  • Clinical judgment concerning other safety issues

Who the study is looking for

  • Aged +18 years
  • Hospitalized for acute decompensated heart failure in a tertiary referral hospital
  • Owning a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data (either the patient or the caregiver)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.