Personalized exercise programs for patients with dilated cardiomyopathy using Apple Watch
activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch
NA · University Hospital Heidelberg · NCT04359238
This study is testing if personalized exercise programs using an Apple Watch can help people with dilated cardiomyopathy improve their heart health and overall quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Locations | 1 site (Heidelberg, Baden-Württemberg) |
| Trial ID | NCT04359238 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of individualized exercise programs on patients with dilated cardiomyopathy over a 13-month period. A total of 300 participants will be enrolled, with two-thirds engaging in a tailored sports program while the remaining third will serve as a control group. Participants will receive an Apple Watch to monitor their activity and symptoms, and various health metrics will be assessed, including maximum oxygen intake and cardiac function. Blood samples will be collected to explore the relationship between exercise and cardiovascular health, alongside quality of life assessments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 diagnosed with non-ischemic dilated cardiomyopathy and a left ventricular ejection fraction of 45% or less.
Not a fit: Patients with physical disabilities or orthopedic conditions that prevent them from participating in exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise regimens that enhance the health outcomes of patients with dilated cardiomyopathy.
How similar studies have performed: Other studies have shown promising results with exercise interventions in heart failure patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of non-ischemic, dilated cardiomyopathy (DCM) * EF ≤ 45% * NYHA I-III * Age 18 to 65 years * The patient understood the study concept and the declaration of consent and signed and dated the declaration of consent Exclusion Criteria: * Physical disability that is not compatible with exercise in the study * Orthopedic diseases such as osteoarthritis or changes in the spine that lead to restrictions that are not compatible with exercise in the study * Syncope within the past 3 months * Pregnancy
Where this trial is running
Heidelberg, Baden-Württemberg
- Department III of Internal Medicine, University Hospital Heidelberg — Heidelberg, Baden-Württemberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Benjamin Meder, Prof. Dr. — University Hospital Heidelberg
- Study coordinator: Benjamin Meder, Prof. Dr.
- Email: benjamin.meder@med.uni-heidelberg.de
- Phone: 0049 (0)6221 56-37948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiomyopathy, Dilated, Heart Failure, Exercise, SmartWatch, Wearables, Digital Health, Dilated Cardiomyopathy