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Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07394621
Enrollment
37
Registered
2026-02-06
Start date
2026-01-02
Completion date
2026-07-15
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kinesiophobia (Fear of Movement)

Keywords

kinesiophobia, functional capacity, LVAD

Brief 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.

Interventions

DIAGNOSTIC_TESTPhysical Activity Recommandations

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

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tampa Kinesiophobia ScaleFrom enrollment to the 4 weeks after the implementationThe Tampa Scale of Kinesiofobia (TSK) is a widely used patient-reported outcome measure designed to quantify a patient's fear of movement and fear of (re)injury. It was originally developed to assess patients with chronic low back pain, but it has since been validated for various populations. It is a 17-item questionnaire where each item is scored on a 4-point Likert scale, ranging from "strongly disagree" to "strongly agree". While cut-off values can vary by population, a score higher than 37 is often considered to represent high kinesiofobia.

Secondary

MeasureTime frame
2-Minute Walk TestFrom enrollment to the 4 weeks after the implementation
30 Seconds Sit to Stand Test (30STS)From enrollment to the 4 weeks after the implementation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026