An observational study in Heart Failure and Heart Failure, Diastolic, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Johannes Gutenberg University Mainz · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 193 is close to the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with an age of 45 years or older with a diagnosis of heart failure with preserved ejection fraction (HFpEF)
Diagnosis of HFpEF
Exclusion Criteria:
Participants with physical activity impairment primarily due to conditions other than HF such as:
Individuals with heart failure receiving standard medical care
Behavioral: No Intervention: Observational Cohort
Individuals with heart failure receiving a pedometer for measurement of daily step count
Behavioral: Intervention Group 1
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
Individualized app-based coaching via a smartphone
no Intervention
pedometer-based tracking of physical activity
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
Time frame: 12 weeks
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))
Time frame: 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
Time frame: 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))
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Correlations of gait speed
Correlations of gait speed during an intermittent supervised test to data assessed in patients' home environment
Time frame: 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
Time frame: 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)
Time frame: 12 weeks
Difference in biomarkers of autonomic function (change from baseline to 6-week follow-up)
Difference in biomarkers of autonomic function from baseline to 6-week follow-up (e.g. heart rate variability)
Time frame: 6 weeks
Difference in biomarkers of autonomic function (change from baseline to 12-week follow-up)
Difference in biomarkers of autonomic function from baseline to 12-week follow-up (e.g. heart rate variability)
Time frame: 12 weeks
Difference in biomarkers of heart failure (change from baseline to 6-week follow-up)
Difference in biomarkers of heart failure from baseline to 6-week follow-up (e.g., NT-proBNP)
Time frame: 6 weeks
Difference in biomarkers of heart failure (change from baseline to 12-week follow-up)
Difference in biomarkers of heart failure from baseline to 12-week follow-up (e.g., NT-proBNP)
Time frame: 12 weeks
Difference in biomarkers of cardio-vascular diseases (change from baseline to 6-week follow-up)
Difference in biomarkers of cardiovascular diseases from baseline to 6-week follow-up (e.g., troponin)
Time frame: 6 weeks
Difference in biomarkers of cardio-vascular diseases (change from baseline to 12-week follow-up)
Difference in biomarkers of cardiovascular diseases from baseline to 12-week follow-up (e.g., troponin)
Time frame: 12 weeks
Difference in biomarkers of metabolic diseases (change from baseline to 6-week follow-up)
Difference in biomarkers of metabolic diseases from baseline to 6-week follow-up (e.g., HbA1c)
Time frame: 6 weeks
Difference in biomarkers of metabolic diseases (change from baseline to 12-week follow-up)
Difference in biomarkers of metabolic diseases from baseline to 12-week follow-up (e.g., HbA1c)
Time frame: 12 weeks
Difference in biomarkers of renal diseases (change from baseline to 6-week follow-up)
Difference in biomarkers of renal diseases from baseline to 6-week follow-up (e.g., eGFR)
Time frame: 6 weeks
Difference in biomarkers of renal diseases (change from baseline to 12-week follow-up)
Difference in biomarkers of renal diseases from baseline to 12-week follow-up (e.g., eGFR)
Time frame: 12 weeks
Difference in biomarkers of cancer (change from baseline to 6-week follow-up)
Difference in biomarkers of cancer from baseline to 6-week follow-up (e.g., LDH)
Time frame: 6 weeks
Difference in biomarkers of cancer (change from baseline to 12-week follow-up)
Difference in biomarkers of cancer from baseline to 12-week follow-up (e.g., LDH)
Time frame: 12 weeks
Difference in biomarkers of pulmonary diseases (change from baseline to 6-week follow-up)
Difference in biomarkers of pulmonary diseases from baseline to 6-week follow-up (e.g., FEV1)
Time frame: 6 weeks
Difference in biomarkers of pulmonary diseases (change from baseline to 12-week follow-up)
Difference in biomarkers of pulmonary diseases from baseline to 12-week follow-up (e.g., FEV1)
Time frame: 12 weeks
Difference in biomarkers of inflammation (change from baseline to 6-week follow-up)
Difference in biomarkers of inflammation from baseline to 6-week follow-up (e.g., C-reactive protein)
Time frame: 6 weeks
Difference in biomarkers of inflammation (change from baseline to 12-week follow-up)
Difference in biomarkers of inflammation from baseline to 12-week follow-up (e.g., C-reactive protein)
Time frame: 12 weeks
Difference in biomarkers of immunity (change from baseline to 6-week follow-up)
Difference in biomarkers of immunity from baseline to 6-week follow-up (e.g., leukocytes)
Time frame: 6 weeks
Difference in biomarkers of immunity (change from baseline to 12-week follow-up)
Difference in biomarkers of immunity from baseline to 12-week follow-up (e.g., leukocytes)
Time frame: 12 weeks
Difference in biomarkers of oxidative stress (change from baseline to 6-week follow-up)
Difference in biomarkers of oxidative stress from baseline to 6-week follow-up (e.g., monocytes)
Time frame: 6 weeks
Difference in biomarkers of oxidative stress (change from baseline to 12-week follow-up)
Difference in biomarkers of oxidative stress from baseline to 12-week follow-up (e.g., monoytes)
Time frame: 12 weeks
Difference in biomarkers of hypercoagulability (change from baseline to 6-week follow-up)
Difference in biomarkers of hypercoagulability from baseline to 6-week follow-up (e.g. mean platelet volume)
Time frame: 6 weeks
Difference in biomarkers of hypercoagulability (change from baseline to 12-week follow-up)
Difference in biomarkers of hypercoagulability from baseline to 12-week follow-up (e.g., mean platelet volume)
Time frame: 12 weeks
Difference in biomarkers of vascular/endothelial function (change from baseline to 6-week follow-up)
Difference in biomarkers of vascular/endothelial function from baseline to 6-week follow-up (e.g. pulse-wave velocity)
Time frame: 6 weeks
Difference in biomarkers of vascular/endothelial function (change from baseline to 12-week follow-up)
Difference in biomarkers of vascular/endothelial function from baseline to 12-week follow-up (e.g. pulse-wave velocity)
Time frame: 12 weeks
Difference in biomarkers of carotid atherosclerosis (change from baseline to 6-week follow-up)
Difference in biomarkers of carotid atherosclerosis from baseline to 6-week follow-up (e.g., intima-media-thickness)
Time frame: 6 weeks
Difference in biomarkers of carotid atherosclerosis (change from baseline to 12-week follow-up)
Difference in biomarkers of carotid atherosclerosis from baseline to 12-week follow-up (e.g., intima-media-thickness)
Time frame: 12 weeks
Difference in biomarkers of methylation (change from baseline to 6-week follow-up)
Difference in biomarkers of methylation from baseline to 6-week follow-up (e.g., CpG methylation)
Time frame: 6 weeks
Difference in biomarkers of methylation (change from baseline to 12-week follow-up)
Difference in biomarkers of methylation from baseline to 12-week follow-up (e.g., CpG methylation)
Time frame: 12 weeks
Difference in anthropometrics (change from baseline to 6-week follow-up)
Difference in anthropometrics from baseline to 6-week follow-up (e.g., BMI)
Time frame: 6 weeks
Difference in anthropometrics (change from baseline to 12-week follow-up)
Difference in anthropometrics from baseline to 12-week follow-up (e.g., BMI)
Time frame: 12 weeks
Difference in biomarkers of psychosomatic diseases (change from baseline to 12-week follow-up)
Difference in biomarkers of psychosomatic diseases from baseline to 12-week follow-up (e.g, PHQ-9)
Time frame: 12 weeks
Difference in biomarkers of physical activity
Difference in biomarkers of physical activity (e.g., step count)
Time frame: 12 weeks
Difference in biomarkers of sedentary daytime activities
Difference in biomarkers of sedentary daytime activities (e.g., sleeping time)
Time frame: 12 weeks
Differences in accelerometry
Differences in accelerometry (e.g., measured with the Dynaport MoveMonitor)
Time frame: 12 weeks
Evaluation of compliance of study participants with the mobile devices
Explorative evaluation of compliance as assessed with technical data from the mobile devices (e.g. wearing time) and a qualitative questionnaire on device experience (allowing to evaluate inter alia feasibility and wearability)
Time frame: 12 weeks
Evaluation of functionality of the mobile devices
Explorative evaluation of device functionality (e.g., as measured by number of data points per observation period)
Time frame: 12 weeks
Evaluation of realibility of the mobile devices
Explorative evaluation of realibility of mobile device measurements (e.g. by comparing systolic blood pressure measurements between mobile devices and routine measurements)
Time frame: 12 weeks
Plan to share: No
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Johannes Gutenberg University Mainz