RecruitingNot ApplicableNCT07394621

Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices

Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices


Sponsor

Marmara University

Enrollment

37 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this prospective and cross-sectional observational study is to learn if the presence and changes in kinesiofobia (fear of movement) affect functional capacity levels in heart failure patients who are transplant candidates and have been implanted with a Left Ventricular Assist Device (LVAD). The main questions it aims to answer are: i) Does the level of kinesiofobia change significantly 1 month after LVAD implantation? ii) Do changes in kinesiofobia levels predict changes in functional exercise capacity (measured by the 2-Minute Walk Test and 30-Second Sit-to-Stand Test)? Researchers will compare pre-discharge (baseline) measurements to 1-month post-discharge follow-up measurements to see if improvements in kinesiofobia correlate with improved functional mobility and endurance. Participants will: i) Complete the Tampa Scale of Kinesiofobia (TSK) to assess their fear of movement. ii) Perform the 2-Minute Walk Test (2MWT) to evaluate functional exercise capacity and mobility. iii) Perform the 30-Second Sit-to-Stand Test (30STS) to determine functional endurance and lower extremity performance. iv) Receive standardized physical activity recommendations upon discharge. v) Return for a follow-up assessment one month later to repeat the same battery of tests.


Eligibility

Inclusion Criteria5

  • 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 Criteria4

  • 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.

Interventions

DIAGNOSTIC_TESTPhysical Activity Recommandations

Patients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives.


Locations(1)

Marmara University Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

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NCT07394621


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