Heart FailureMyoMobileNCT04940312
MyoMobile Study: App-based Activity Coaching in Patients with Heart Failure and Preserved Ejection Fraction
An observational study of Heart Failure and Heart Failure, Diastolic, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure, Heart Failure, Diastolic
- What is being tested?
- App-based physical activity coaching and Intervention Group 1
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 193 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2020to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with an age of 45 years or older with a diagnosis of heart failure with preserved ejection fraction (HFpEF)
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Heart Failure, Diastolic
- Being tested
- App-based physical activity coaching, No Intervention: Observational Cohort, Intervention Group 1
- Keywords
- Heart failure with preserved ejection fraction (HFpEF), Activity coaching, Smartphone App, Systems Medicine, Clinical Epidemiology
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based physical activity coachingBehavioural
Individualized app-based coaching via a smartphone
No Intervention: Observational CohortBehavioural
no Intervention
Intervention Group 1Behavioural
pedometer-based tracking of physical activity
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Individuals with heart failure receiving standard medical care Receives: Behavioral: No Intervention: Observational Cohort | |
| Intervention Group 1 (pedometer-monitoring only) | Individuals with heart failure receiving a pedometer for measurement of daily step count Receives: Behavioral: Intervention Group 1 | |
| Intervention Group 2 (app-based coaching) | Individuals with heart failure receiving an individualized, app-based physical activity coaching on the basis of pedometer-based assessment of daily step count Receives: Behavioral: App-based physical activity coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (13)
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))
Measured: 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
Measured: 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))
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Correlations of gait speed
Correlations of gait speed during an intermittent supervised test to data assessed in patients' home environment
Measured: 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
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start11 Nov 2020
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, McRoberts B.V., Umana Medical Technologies Ltd., International Business Machines (IBM)
- Responsible party
- Principal investigator, Philipp Wild, MD, MSc, University Medical Center Mainz
- Investigators
- Philipp Wild, Univ.-Prof. Dr. med., MSc, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940312
- Sponsor's protocol ID
- UMCM-2020EPI06
- Acronym
- MyoMobile
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2021
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40110212
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04940312
- Acronym / sponsor ID
- MyoMobile / UMCM-2020EPI06
- Conditions
- Heart Failure, Heart Failure, Diastolic
- Keywords
- Heart failure with preserved ejection fraction (HFpEF), Activity coaching, Smartphone App, Systems Medicine, Clinical Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Bayer, McRoberts B.V., Umana Medical Technologies Ltd., International Business Machines (IBM)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | – | Behavioral: No Intervention: Observational CohortIndividuals with heart failure receiving standard medical care |
| Intervention Group 1 (pedometer-monitoring only) | – | Behavioral: Intervention Group 1Individuals with heart failure receiving a pedometer for measurement of daily step count |
| Intervention Group 2 (app-based coaching) | – | Behavioral: App-based physical activity coachingIndividuals with heart failure receiving an individualized, app-based physical activity coaching on the basis of pedometer-based assessment of daily step count |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with an age of 45 years or older with a diagnosis of heart failure with preserved ejection fraction (HFpEF)
Key inclusion criteria (8 listed)
- Age ≥ 45 years
- Diagnosis of HFpEF
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based physical activity coachingIndividualized app-based coaching via a smartphone | Behavioural | Intervention Group 2 (app-based coaching) |
| No Intervention: Observational Cohortno Intervention | Behavioural | Usual Care Group |
| Intervention Group 1pedometer-based tracking of physical activity | Behavioural | Intervention Group 1 (pedometer-monitoring only) |
Primary outcome
Average daily step count (all groups)
Time frame: 12 weeks
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
13 secondary outcomes
Difference in E/E' ratio (change from baseline to 12-week follow-up)
Time frame: 12 weeks
Difference in left ventricular ejection fraction (LVEF) from baseline to 12-week follow-up (V4)
Time frame: 12 weeks
Difference in quality of life (change from baseline to 12-week follow-up)
Time frame: 12 weeks
Difference in heart rate variability (HRV) (change from baseline to 12-week follow-up)
Time frame: 12 weeks
Difference in peak VO2 (change from baseline to 12-week follow-up)
Time frame: 12 weeks
Change in daily non-sedentary daytime activity from baseline to 12-week follow-up
Time frame: 12 weeks
Difference in gait speed (change from baseline to 12-week follow-up)
Time frame: 12 weeks
Difference in NT-proBNP from baseline to 12-week follow-up
Time frame: 12 weeks
Difference in FEV1 (change from baseline to 12-week follow-up)
Time frame: 12 weeks
Difference in the augmentation index (change from baseline to 12-week follow-up)
Time frame: 12 weeks
Correlations of gait speed
Time frame: 12 weeks
Difference in METs (change 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)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Derived from this study: PubMed 40110212Zeid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Wild, Univ.-Prof. Dr. med., MSc principal investigator
University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure, Diastolic, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily step count (all groups) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.