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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: mHealth Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Health Arm	Behavioral: mHealth Intervention; 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.
No Intervention: Control Arm; The Control Arm will receive standard of care including tailored prescription of physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 6-minute walking distance (6MWD)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)	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)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength - measured using the Medical Research Council (MRC) Sum Score	The total MRC sum score ranges from 0 (total paralysis) to 60 (normal strength).	6 months
Upper limb strenght - measured by hand-held dynamometry	This instrument is scored using force production in kilograms (0-90)	6 months
Rectus femoris muscle diameter		6 months
Physical function measured by the Short Physical Performance Battery score	Each task is scored from 0 to 4, with 4 being the best, and a total battery score of 12 points	6 months
Participant reported quality of life - measured using the Minnesota living with heart failure questionnaire (MLHFQ)	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 months
NT-proBNP levels		6 months
Readmission rate for Heart Failure		6 months
Participant reported time dedicated to exercise recommendations		6 months
Number of steps -measured using the built-in smartphone pedometer		6 months
User satisfaction with the mHealth application (only experimental arm), measured by a customer satisfaction survey specifically designed for the trial		6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IIBSP-MRE-2020-86

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No