Home exercise program using mobile technology for patients with a HeartMate 3 device
Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation
NA · University of Pennsylvania · NCT06291922
This study is testing whether a home exercise program using mobile technology can help people with a HeartMate 3 device feel stronger and improve their quality of life compared to those who just get regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 4 sites (Detroit, Michigan and 3 other locations) |
| Trial ID | NCT06291922 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a home-based exercise program utilizing mobile technology on patients who have recently received a HeartMate 3 left ventricular assist device (LVAD). Participants will be randomized into two groups: one receiving an individualized exercise intervention and the other receiving usual care. The study will assess various outcomes including physical activity, frailty, muscle mass, and quality of life through baseline measurements and ongoing monitoring using activity tracking devices. The intervention group will receive tailored exercise prescriptions and support, while the control group will be encouraged to increase their activity levels with standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently received a HeartMate 3 LVAD and can ambulate independently.
Not a fit: Patients with major comorbidities or limitations that interfere with exercise training, such as significant orthopedic or neurologic issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve physical activity levels, muscle mass, and overall quality of life for patients with LVADs.
How similar studies have performed: Previous studies have shown positive outcomes with exercise interventions in heart failure patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 18 years of age 2. Newly implanted with a HeartMate 3™ LVAD for the first time 3. Able to ambulate independently (with or without the use of an assistive device) 4. Owns a smartphone with Internet connection 5. Patient will be discharged home with LVAD or patient will be living at home with LVAD within 45 days of index discharge Exclusion Criteria: 1\. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina)
Where this trial is running
Detroit, Michigan and 3 other locations
- Henry Ford Health — Detroit, Michigan, United States (RECRUITING)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- University of Utah Health — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Himabindu Vidula, MD — University of Pennsylvania
- Study coordinator: Clinical Research Coordinator
- Email: sadie.butcher@pennmedicine.upenn.edu
- Phone: 215-615-4480
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: Heart Failure, Left ventricular assist device, Exercise, Ventricular assist device, HeartMate 3