Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure: a Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Change in 6-minute walking distance (6MWD)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •NYHA IV patients
- •Currently listed for heart transplant
- •Left ventricular assist device recipient
- •Ventricular arrhythmia within prior 6 months
- •Uncontrolled arterial hypertension or resting heart rate \>100 bpm
- •Acute myocarditis or pericarditis
- •Severe aortic stenosis
- •Hypertrophic obstructive cardiomyopathy
- •Advanced AV block
- •Muscle-skeletal or neurologic disease preventing to perform study procedures
Outcomes
Primary Outcomes
Change in 6-minute walking distance (6MWD)
Time Frame: 6 months
Secondary Outcomes
- Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)(6 months)