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Completed

NCT Number: NCT04848298

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in 6-minute walking distance (6MWD)

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

    Results will be reported in categories (low activity levels, moderate activity levels or high activity levels) and as a continuous variable (MET minutes a week)

Other outcomes

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

    Time frame: 6 months

    The total MRC sum score ranges from 0 (total paralysis) to 60 (normal strength).

  2. Upper limb strenght - measured by hand-held dynamometry

    Time frame: 6 months

    This instrument is scored using force production in kilograms (0-90)

  3. Rectus femoris muscle diameter

    Time frame: 6 months

  4. Physical function measured by the Short Physical Performance Battery score

    Time frame: 6 months

    Each task is scored from 0 to 4, with 4 being the best, and a total battery score of 12 points

  5. Participant reported quality of life - measured using the Minnesota living with heart failure questionnaire (MLHFQ)

    Time frame: 6 months

    Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life

  6. NT-proBNP levels

    Time frame: 6 months

  7. Readmission rate for Heart Failure

    Time frame: 6 months

  8. Participant reported time dedicated to exercise recommendations

    Time frame: 6 months

  9. Number of steps -measured using the built-in smartphone pedometer

    Time frame: 6 months

  10. User satisfaction with the mHealth application (only experimental arm), measured by a customer satisfaction survey specifically designed for the trial

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: mRehab

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2021
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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