Kinesiophobia (Fear of Movement)NCT07394621
Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices
A study testing Physical Activity Recommandations in people with Kinesiophobia (Fear of Movement), run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kinesiophobia (Fear of Movement)
- What is being tested?
- Physical Activity Recommandations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Health Sciences
Istanbul, 34854
About this study
Official title: 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:
- 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.
Read more
Participants will:
- 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.
- Conditions
- Kinesiophobia (Fear of Movement)
- Being tested
- Physical Activity Recommandations
- Keywords
- kinesiophobia, functional capacity, LVAD
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity RecommandationsDiagnostic test
Also called 30 seconds sit to stand test, 2 minute walk test
Patients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Recommendation Group | Experimental | Patient who recevied physical activity recommendations after LVAD implementation Receives: Diagnostic Test: Physical Activity Recommandations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale
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.
Measured: From enrollment to the 4 weeks after the implementation
Secondary outcomes (2)
2-Minute Walk Test
Measured: From enrollment to the 4 weeks after the implementation
30 Seconds Sit to Stand Test (30STS)
Measured: From enrollment to the 4 weeks after the implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start2 Jan 2026
- Primary completion15 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kinesiophobia (Fear of Movement)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafet Umut Erdoğan, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394621
- Sponsor's protocol ID
- 25.01.2024/22
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices
- ClinicalTrials.gov ID
- NCT07394621
- Acronym / sponsor ID
- 25.01.2024/22
- Conditions
- Kinesiophobia (Fear of Movement)
- Keywords
- kinesiophobia, functional capacity, LVAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Recommendation Group | Experimental | Diagnostic Test: Physical Activity RecommandationsPatient who recevied physical activity recommendations after LVAD implementation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity RecommandationsAlso: 30 seconds sit to stand test, 2 minute walk testPatients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives. | Diagnostic test | Exercise Recommendation Group |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Recommandations in people with Kinesiophobia (Fear of Movement), run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Kinesiophobia Scale (time frame: From enrollment to the 4 weeks after the implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.