Fear of Movement After Left Ventricular Assist Device (LVAD) Implantation
Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices
This study will see if changes in fear of movement after LVAD implantation relate to walking distance and sit-to-stand ability in heart transplant candidates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Sex | All |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07394621 on ClinicalTrials.gov |
What this trial studies
This prospective observational study compares kinesiophobia and functional capacity measured at pre-discharge (baseline) and one month after discharge in LVAD recipients who are heart transplant candidates. Participants complete the Tampa Scale of Kinesiophobia and perform the 2-Minute Walk Test and 30-Second Sit-to-Stand Test at both time points. Standard physical activity recommendations given at discharge are recorded and considered in the analyses. Researchers will analyze whether changes in kinesiophobia predict parallel changes in mobility and endurance.
Who should consider this trial
Good fit: Ideal candidates are heart transplant candidates with an implanted LVAD, LVEF <30%, no early post-operative complications, able to read and write, and referred at discharge by their cardiologist.
Not a fit: Patients with active post-implantation infection, new psychiatric or musculoskeletal problems that impair adaptation, or those requiring acute rehospitalization during follow-up are unlikely to benefit from the protocol.
Why it matters
Potential benefit: If successful, the findings could help identify patients whose fear of movement limits recovery and guide targeted rehabilitation or counseling to improve mobility after LVAD.
How similar studies have performed: Prior work has linked kinesiophobia to reduced functional capacity in other cardiac and orthopedic populations, but applications specifically in LVAD recipients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being a heart transplant candidate and having undergone LVAD implantation, * Having a left ventricular ejection fraction (LVEF) \<30%, * Not having developed any surgical or medical complications in the early period after implantation, * Being referred to the study by a cardiologist at the time of discharge, * Being able to read and write and volunteering to participate in the study. Exclusion Criteria: * Those with evidence of active infection following implantation, * Psychiatric problems developing after LVAD implantation that interfere with cognitive adaptation, * Musculoskeletal problems developing after LVAD implantation, * Cases experiencing acute cardiac problems requiring hospitalization during follow-up.
Where this trial is running
Istanbul
- Marmara University Faculty of Health Sciences — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Rafet Umut Erdoğan
- Email: rafetumuterdogan@gmail.com
- Phone: +905542398786
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.