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NCT Number: NCT07394621

Kinesiophobia 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Health Sciences

Istanbul, 34854, Turkey (Türkiye)

Location status: Recruiting

Location contact

Rafet Umut Erdoğan

CONTACT

[email protected]

+905542398786

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Activity Recommandations

Diagnostic Test

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

Other names: 30 seconds sit to stand test, 2 minute walk test

Primary outcomes

  1. 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.

Secondary outcomes

  1. 2-Minute Walk Test

    Time frame: From enrollment to the 4 weeks after the implementation

  2. 30 Seconds Sit to Stand Test (30STS)

    Time frame: From enrollment to the 4 weeks after the implementation

Study contacts

Contact information is provided by the study sponsor or research team.

Rafet Umut Erdoğan

CONTACT

[email protected]

+905542398786

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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