Personalized App-Based Coaching Improves Physical Activity in Patients With HFpEF Compared to Standard Care – A Randomized Parallel Group Trial (MyoMobile Study)
Abstract Body (Do not enter title and authors here): Hypothesis There is limited evidence for effective lifestyle therapies in heart failure with preserved ejection fraction (HFpEF). This trial evaluated the impact of a personalized app-based coaching intervention on physical activity (PA) in HFpEF patients.
Study Design and Methods The MyoMobile trial was a single-center, three-armed, parallel group, randomized clinical trial. Participants received 12 weeks of either app-based PA tracking plus coaching (‘coaching arm’), app-based tracking without coaching (‘tracking arm’), or standard care in a 1:0.75:1 ratio. PA was continuously monitored using various wearables. The MyoMobile app was developed with and without a coaching function.
Sample Size The intention-to-treat sample included N=185 HFpEF participants, with a per-protocol sample of N=172.
Population Studied Individuals diagnosed with HFpEF.
Interventions Participants were assigned to app-based PA tracking plus coaching, app-based tracking without coaching, or standard care.
Power Calculation A sample size of 62 participants per group was required to achieve 90% power at a two-sided α of 0.05 for the primary endpoint.
Primary Endpoint The primary endpoint was the change in daily step count after 12 weeks in the coaching arm compared to standard care.
Secondary Endpoints Secondary endpoints included comparisons of the other study arms and changes in subclinical function markers.
Outcome The intention-to-treat sample included N=185 HFpEF participants (age 70.1±8.6 years, 34.6% women; coaching arm N=69; tracking arm N=50; standard care N=66). Median NT-proBNP was 418 (160/894). NYHA classification: 42.7% class I, 45.4% class II, 11.9% class III/IV. The trial showed a significant increase in daily step count in the coaching arm versus standard care (Δ step count: 1,324, 95% CI 497; 2,151, p=0.002; coaching arm: step countPRE: 6,009±2,283, step countPOST: 6,872±3,148; standard care: step countPRE: 5,636±2,142; step countPOST: 5,240±2,767). Secondary endpoint analysis highlighted greater efficacy of app-based coaching over tracking alone in enhancing PA (Δ step count: 1,048, 95% CI 168; 1,929, p=0.021; tracking arm: step countPRE: 6,117±2,236, step countPOST: 5,910±2,909), with modest improvements in heart rate recovery (βSD: 0.65, 95% CI 0.30; 1.00, p=0.0006) in the coaching arm. No difference in step count was observed between the tracking arm and standard care (Δ step count: 182, 95% CI -617; 980, p=0.66), and no changes were observed for other secondary outcomes.
Zeid, Silav
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Pies, Tanja
( Bayer AG
, Wuppertal
, Germany
)
Michal, Matthias
( University Medical Center of the Johannes Gutenberg-University Mainz
, Mainz
, Germany
)
Simon, Perikles
( Faculty of Social Science, Media and Sport, Johannes Gutenberg-University Mainz
, Mainz
, Germany
)
Dinh, Wilfried
( Bayer AG
, Wuppertal
, Germany
)
Prochaska, Jürgen
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Wild, Philipp
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Buch, Gregor
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Söhne, Jakob
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Velmeden, David
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Kerber, Anna
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Kazemi-asrar, Fawad
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Fooss, Benedikt
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Ten Cate, Vincent
( University Medical Center of the Johannes Gutenberg University Mainz
, Mainz
, Germany
)
Muenzel, Thomas
( University Medical Center of the Johannes Gutenberg-University Mainz
, Mainz
, Germany
)
Author Disclosures:
Silav Zeid:DO NOT have relevant financial relationships
| Tanja Pies:No Answer
| Matthias Michal:No Answer
| Perikles Simon:DO NOT have relevant financial relationships
| Wilfried Dinh:No Answer
| Jürgen Prochaska:No Answer
| Philipp Wild:No Answer
| Gregor Buch:DO NOT have relevant financial relationships
| Jakob Söhne:No Answer
| David Velmeden:No Answer
| Anna Kerber:No Answer
| Fawad Kazemi-Asrar:No Answer
| Benedikt Fooss:No Answer
| Vincent ten Cate:No Answer
| Thomas Muenzel:DO NOT have relevant financial relationships
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