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Preventive Cardiology and Medical Prevention
Center for Cardiology

Clinical Epidemiology and Systems Medicine
Center for Thrombosis and Hemostasis

Visual Universitätsmedizin Mainz

MyoMobile

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A randomized parallel group study to investigate the effects of individualized app-based coaching on physical activity and myocardial and vascular function of patients with heart failure and preserved ejection fraction compared to standard care

  • Coordinating Principal Investigator:
    Philipp Wild, Univ.-Prof. Dr., MSc

Study Design

A randomized, controlled observational parallel group cohort study

Study Population

A total of at least 171 individuals aged >45 years with confirmed heart failure

Status

Recruitment ongoing (Study Initiation: November 2020)

Objectives

Primary objective:

The primary efficacy endpoint is the change in average daily step count between the baseline phase (mean of data collected during the period prior to randomization) and the end of the intervention (mean of data collected during week 12) comparing standard care to a 12-week individualized app-based activity coaching.

Secondary objectives:

  • The secondary endpoints include assessment of the effects of physical activity between baseline and 12 weeks of intervention as well as between intervention groups for the following parameters:

    • Evaluation of autonomous function and correlations assessed by acceleration measurement.
    • Change in gait speed
    • Physical endurance (spiroergometry)
    • Change in parameters of heart rate variability (HRV)
    • Change in daily non-sedentary daytime activity
    • Change in N-terminal brain natriuretic peptide (BNP)
    • Change in quality of life (KCCQ)

Study Schedule

Duration of the study per participant: 12 weeks

  • Reference group: standard care
  • Intervention group 1: Pedometer-based measurement of daily step count.
  • Intervention group 2: Pedometer-based measurement of daily step count and personalized, app-based activity coaching.

Summary

In HF patients, physical inactivity and a sedentary lifestyle lead to disease progression and increased mortality, and an increase of physical activity is positively correlated with improved outcome. Guidelines from the Heart Failure Society of America recommend at least 30 minutes of moderate-intensity activity for ≥ 5 days/week (i.e. at least 150 min/week). Unfortunately, exercise recommendations are poorly implemented in daily clinical practice and even patients enrolled in supervised exercise training programs have been reported to show low adherence. The MyoMobile study has been designed to assess the effect of a 12-week, app-based coaching program on physical activity in patients with HFpEF. Physical activity including daily step count will be assessed by accelerometry and, in addition, a pedometer will be used to measure the daily step count and provide direct feedback to the patient. Accelerometers provide an objective and continuous assessment of physical activity during patients' daily life over longer periods and may therefore reflect the true effect of the activity coaching intervention on physical activity more accurately than intermittent supervised exercise tests such as the six minute walk test. These efforts are complemented by a comprehensive (sub)clinical and molecular characterization of HFpEF patients at baseline and after the follow-up period of 12 weeks. In order to evaluate the potential effect of awareness for physical activity and of surveillance, due to participants wearing a pedometer throughout the study period, two intervention groups will be investigated. This will allow for the effect of an individualized, app-based coaching intervention, compared to standard care in patients with HFpEF, to be deciphered. Furthermore, the study will establish a biobank to investigate hypotheses related to HFpEF and physical activity. Moreover, research will be conducted on various aspects of heart failure and its risk factors, metabolic disorders, immune system, cancer, pulmonary and psychosomatic diseases.

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