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
- Diseases
- Heart failure
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.