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

NCT04848298 | Completed

• 1 other identifier: IIBSP-MRE-2020-86
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walking distance (6MWD)

  6 months

Secondary Outcomes (1)

• Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)

  6 months

Other Outcomes (10)

• Muscle strength - measured using the Medical Research Council (MRC) Sum Score

  6 months

• Upper limb strenght - measured by hand-held dynamometry

  6 months

• Rectus femoris muscle diameter

  6 months

Study Arms (2)

Mobile Health Arm

EXPERIMENTAL

Behavioral: mHealth Intervention

Control Arm

NO INTERVENTION

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

Interventions

mHealth Intervention BEHAVIORAL

The Mobile Health Arm will receive standard of care including tailored prescription of physical activity as well as the mobile health intervention, which will have the following features: * Goal setting for frequency and duration of exercise sessions * Graphic feedback and reinforcement with educational and motivational messages tailored to user's exercise adherence. * Problem-solving support * Library with educational tips and information regarding physical exercise.

Mobile Health Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sonia Mirabet, Ph. D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: April 22, 2021
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

ES (1)