Skip to main content
Clinical Trials/NCT04848298
NCT04848298
Completed
N/A

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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country116 target enrollmentApril 22, 2021
ConditionsHeart Failure

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2021
End Date
June 10, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party
Sponsor

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)

Study Sites (1)

Loading locations...

Similar Trials