Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices
Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye), 34854
- Marmara University Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Recommendation Group
Patient who recevied physical activity recommendations after LVAD implementation
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Patients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Kinesiophobia Scale
Time Frame: From enrollment to the 4 weeks after the implementation
|
The 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.
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From enrollment to the 4 weeks after the implementation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
2-Minute Walk Test
Time Frame: From enrollment to the 4 weeks after the implementation
|
From enrollment to the 4 weeks after the implementation
|
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30 Seconds Sit to Stand Test (30STS)
Time Frame: From enrollment to the 4 weeks after the implementation
|
From enrollment to the 4 weeks after the implementation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.01.2024/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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