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

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

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: mHealth Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04848298

IIBSP-MRE-2020-86

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Mobile Health Arm

Experimental group

Treatment:

Behavioral: mHealth Intervention

Control Arm

No Intervention group

Description:

The Control Arm will receive standard of care including tailored prescription of physical activity