MyoMobile Study: App-based Activity Coaching in Patients With Heart Failure and Preserved Ejection Fraction

Study Overview
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Brief Summary
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The MyoMobile study is a single-center, randomized, controlled three-armed cohort study with prospective data collection to investigate the effect of a personalized mobile health intervention compared to usual care on the physical activity levels in patients with heart failure and preserved ejection fraction.

Detailed Description
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Heart failure (HF) affects more than 15 million people in Europe and represents the leading cause of hospitalization. The prevalence of HF is increasing, which has been attributed to an ageing population with subsequently higher prevalence of predisposing risk factors (e.g. arterial hypertension, type-2-diabetes, obesity), a better survival, and more effective treatment of precursors (e.g. myocardial infarction). In the community, heart failure with preserved ejection fraction (HFpEF) is the most common HF phenotype. Currently, the benefit of medical therapies is limited to patients with heart failure with reduced ejection fraction (HFrEF) only, whereas no specific medical therapy is currently approved for patients with HFpEF. 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.

Official Title
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A Randomized 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

Conditions
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Heart Failure, Heart Failure, Diastolic

Intervention / Treatment
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* Behavioral: App-based physical activity coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 45 years Diagnosis of HFpEF LVEF > 40% by any imaging modality at screening within 4 months prior to study entry Current HF symptoms as defined as presence of dyspnea according to New York Heart Association [NYHA] functional class I to III at screening visit Stable HF treatment for at least 4 weeks prior to screening At least one of the following 3 criteria need to be fulfilled: (1) NT-proBNP ≥ 300pg/ml; (2) Hospitalization for HF within the past 12 months; (3) Symptom(s) of HF requiring treatment with diuretic(s) for at least 30 days prior to screening visit Wearing time of the physical activity monitor for at least 4 days during the baseline assessment Average daily step count during baseline assessment ≥ 1,000 steps per day and < 10,000 steps per day Exclusion Criteria: Acute decompensated HF requiring augmented therapy with diuretic agents, vasodilator agents, and/or inotropic drugs Participants who are non-ambulatory managed or use mobility assistive devices such as motorized devices or wheelchairs Acute coronary syndrome (including myocardial infarction), cardiac surgery, other major cardiovascular surgery or urgent percutaneous coronary intervention (PCI) within 3 months prior to visit 1 or an elective PCI within 30 days after study enrolment Probable alternative diagnoses that in the opinion of the investigator account for the patient's HF symptoms (i.e., dyspnea, fatigue) Participants with physical activity impairment primarily due to conditions other than HF such as: Participants unwilling or unable to wear or to operate study measurement devices for the phases required Exertional angina Inflammatory or degenerative joint disease Peripheral vascular disease Neurologic disease affecting activity or mobility (e.g. peripheral neuropathy) Foot ulcer (e.g. diabetic foot syndrome) Prosthetic limbs Current chemotherapy and/or radiation therapy for treatment of active cancer Medical or psychological conditions that would jeopardize an adequate and orderly conduct or completion of the study

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Usual Care Group<br>Individuals with heart failure receiving standard medical care | |
| Intervention Group 1 (pedometer-monitoring only)<br>Individuals with heart failure receiving a pedometer for measurement of daily step count | |
| Intervention Group 2 (app-based coaching)<br>Individuals with heart failure receiving an individualized, app-based physical activity coaching on the basis of pedometer-based assessment of daily step count | Behavioral: App-based physical activity coaching<br>* Individualized app-based coaching via a smartphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily step count (all groups) | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in E/E' ratio (change from baseline to 12-week follow-up) | Difference in E/E' ratio (change from baseline (V1) to 12-week follow-up (V4)) | 12 weeks | 
| Difference in left ventricular ejection fraction (LVEF) from baseline to 12-week follow-up (V4) | Difference in LVEF (systolic function) from baseline to 12-week follow-up | 12 weeks | 
| Difference in quality of life (change from baseline to 12-week follow-up) | Difference in quality of life from baseline to 12-week follow-up (measured with The Kansas City Cardiomyopathy Questionnaire (KCCQ)) | 12 weeks | 
| Difference in heart rate variability (HRV) (change from baseline to 12-week follow-up) | Difference in HRV from baseline to 12-week follow-up (measured with 24-hour Holter ECG) | 12 weeks | 
| Difference in peak VO2 (change from baseline to 12-week follow-up) | Difference in peak VO2 from baseline to 12-week follow-up (cardiopulmonary exercise testing) | 12 weeks | 
| Change in daily non-sedentary daytime activity from baseline to 12-week follow-up | Change in daily non-sedentary daytime activity from baseline to 12-week follow-up (composite measure of movement and locomotion as measured by the Dynaport MoveMonitor) (V4) | 12 weeks | 
| Difference in gait speed (change from baseline to 12-week follow-up) | Change in gait speed from baseline to 12-week follow-up | 12 weeks | 
| Difference in NT-proBNP from baseline to 12-week follow-up | Difference in the serum concentration of N-terminal brain natriuretic peptide (NT-proBNP) from baseline to 12-week follow-up | 12 weeks | 
| Difference in FEV1 (change from baseline to 12-week follow-up) | Difference in forced expiratory volume in one second (FEV1) from baseline to 12-week follow-up | 12 weeks | 
| Difference in the augmentation index (change from baseline to 12-week follow-up) | Difference in the augmentation index from baseline to 12-week follow-up. The augmentation index is an indicator of arterial stiffness; higher values indicate a worse outcome | 12 weeks | 
| Correlations of gait speed | Correlations of gait speed during an intermittent supervised test to data assessed in patients' home environment | 12 weeks | 
| Difference in METs (change from baseline to 12-week follow-up) | Change in metabolic equivalents (METs) from baseline to 12-week follow-up | 12 weeks | 
| Difference in daily step count between the intervention groups (change from baseline to 12-week follow-up) | Difference in daily step count from baseline to end of study (comparing the two intervention groups only) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone App, Heart failure with preserved ejection fraction (HFpEF), Activity coaching, Systems Medicine, Clinical Epidemiology