Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Activity Recommandations.
- Who it may be relevant to
- Registry conditions: Kinesiophobia (Fear of Movement). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices
Overview
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.
Interventions
- Diagnostic test Physical Activity Recommandations
Patients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives.
Primary outcome measures
- Tampa Kinesiophobia Scale [Time frame: From enrollment to the 4 weeks after the implementation]
Secondary outcome measures (2)
- 2-Minute Walk Test [Time frame: From enrollment to the 4 weeks after the implementation]
- 30 Seconds Sit to Stand Test (30STS) [Time frame: From enrollment to the 4 weeks after the implementation]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Turkey (Türkiye) · 1 center
- Marmara University Faculty of Health Sciences — Istanbul
Identifiers
NCT: NCT07394621 · 25.01.2024/22