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

Heart Failure Clinical Trial

— mRehab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848298
• Other study ID #: IIBSP-MRE-2020-86
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: April 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Upper limb strenght - measured by hand-held dynamometry	This instrument is scored using force production in kilograms (0-90)	6 months
Other	Rectus femoris muscle diameter		6 months
Other	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
Other	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
Other	NT-proBNP levels		6 months
Other	Readmission rate for Heart Failure		6 months
Other	Participant reported time dedicated to exercise recommendations		6 months
Other	Number of steps -measured using the built-in smartphone pedometer		6 months
Other	User satisfaction with the mHealth application (only experimental arm), measured by a customer satisfaction survey specifically designed for the trial		6 months
Primary	Change in 6-minute walking distance (6MWD)		6 months
Secondary	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