MyoMobile
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
Sponsor study identifier
observational
193
1 country
1
Study Start
November 11, 2020
Actual (reported)Primary Completion
January 31, 2023
Actual (reported)Study Completion
January 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 11, 2020
Actual (reported)February 3, 2021
Actual (reported)June 25, 2021
Actual (reported)January 31, 2023
Actual (reported)January 31, 2023
Actual (reported)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
Difference in E/E' ratio (change from baseline to 12-week follow-up)
12 weeks
Difference in left ventricular ejection fraction (LVEF) from baseline to 12-week follow-up (V4)
12 weeks
Difference in quality of life (change from baseline to 12-week follow-up)
12 weeks
Difference in heart rate variability (HRV) (change from baseline to 12-week follow-up)
12 weeks
Difference in peak VO2 (change from baseline to 12-week follow-up)
12 weeks
Difference in biomarkers of autonomic function (change from baseline to 6-week follow-up)
6 weeks
Difference in biomarkers of autonomic function (change from baseline to 12-week follow-up)
12 weeks
Difference in biomarkers of heart failure (change from baseline to 6-week follow-up)
6 weeks
Individuals with heart failure receiving standard medical care
Individuals with heart failure receiving a pedometer for measurement of daily step count
Individuals with heart failure receiving an individualized, app-based physical activity coaching on the basis of pedometer-based assessment of daily step count
Individualized app-based coaching via a smartphone
no Intervention
Participants with an age of 45 years or older with a diagnosis of heart failure with preserved ejection fraction (HFpEF)
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Zeid S, Prochaska JH, Schuch A, Trobs SO, Schulz A, Munzel T, Pies T, Dinh W, Michal M, Simon P, Wild PS. Personalized app-based coaching for improving physical activity in heart failure with preserved ejection fraction patients compared with standard care: rationale and design of the MyoMobile Study. Eur Heart J Digit Health. 2025 Jan 30;6(2):298-309. doi: 10.1093/ehjdh/ztae096. eCollection 2025 Mar.
Blood * Serum * Plasma (EDTA, citrated, heparinized) * DNA * RNA Urine
Philipp Wild, Univ.-Prof. Dr. med., MSc
University Medical Center Mainz
193 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2021
First Posted
June 25, 2021
Study Start
November 11, 2020
Actual (reported)Exercise Training in Heart Failure With Preserved Ejection Fraction - a Long-term Follow-up
pedometer-based tracking of physical activity
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 31, 2023
Actual (reported)Study Completion
January 31, 2023
Actual (reported)Last Updated
October 4, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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