Clinical trial NCT04848298: Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure
Official title: Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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
* ACS within prior month
* Severe lung disease
* Moderate or severe cognitive impairment
* Unable/unwilling to consent
* Projected life expectancy \<6 months
* Clinical judgment concerning other safety issues

Primary outcomes:
measure: Change in 6-minute walking distance (6MWD)
timeFrame: 6 months
Secondary outcomes:
measure: Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)
timeFrame: 6 months
Other outcomes:
measure: Muscle strength - measured using the Medical Research Council (MRC) Sum Score
timeFrame: 6 months
measure: Upper limb strenght - measured by hand-held dynamometry
timeFrame: 6 months
measure: Rectus femoris muscle diameter
timeFrame: 6 months
measure: Physical function measured by the Short Physical Performance Battery score
timeFrame: 6 months
measure: Participant reported quality of life - measured using the Minnesota living with heart failure questionnaire (MLHFQ)
timeFrame: 6 months
measure: NT-proBNP levels
timeFrame: 6 months
measure: Readmission rate for Heart Failure
timeFrame: 6 months
measure: Participant reported time dedicated to exercise recommendations
timeFrame: 6 months
measure: Number of steps -measured using the built-in smartphone pedometer
timeFrame: 6 months
measure: User satisfaction with the mHealth application (only experimental arm), measured by a customer satisfaction survey specifically designed for the trial
timeFrame: 6 months
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Sonia Mirabet, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: