HemodialysisNCT06696274
Kinesiophobia, Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients
An observational study of Hemodialysis and End Stage Renal Disease (ESRD), run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to investigate the relationship between kinesiophobia and pain, balance, physical performance, quality of life and mental status in patients receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, End Stage Renal Disease (ESRD)
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage renal disease receiving hemodialysis will be enrolled in the study.
Who may be able to join
- Patients with end stage renal disease receiving hemodialysis
- Receiving hemodialysis for more than 3 months
- Being clinically stable
- Volunteering to participate in this stud
Who cannot join
- -Having musculoskeletal disorders that may affect physical performance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirsehir Ahi Evran University
Kırşehir
Merve Firat, +90 850 441 02 44, mervefirat@ahievran.edu.tr
About this study
Official title: Investigation of the Relationship Between Kinesiophobia and Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients
The aim of our study was to investigate the relationship between kinesiophobia and pain, balance, physical performance, quality of life and mental status in patients receiving hemodialysis.
- Conditions
- Hemodialysis, End Stage Renal Disease (ESRD)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
It will be evaluated with the Tampa Kinesiophobia scale.The total score ranges from 17-68, with a score above 37 indicating a high degree of kinesiophobia.
Measured: Day 1
Pain
Will be evaluated with a numeric rating scale. Higher scores indicate worse outcomes.
Measured: Day 1
Balance
It will be assessed with a timed up and go test
Measured: Day 1
Physical performance
It will be evaluated with five-repetition sit-to-stand test
Measured: Day 1
Secondary outcomes (3)
Quality of life
It will be evaluated with the Short Form-36 Quality of Life scale.The subscales rate health from 0 to 100, with 0 indicating poor health and 100 indicating good health.
Measured: Day 1
Mental health
It will be assessed using the Hospital Anxiety and Depression scale. The lowest score they can get from both subscales is 0 and the highest score is 21.High scores indicate high levels of anxiety and depression
Measured: Day 1
Comorbidity level
It will be evaluated with the Charlson Comorbidity Index. Total score is between 0-37. Higher scores indicate worse outcomes and higher risk of death.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start18 Nov 2024
- Primary completionSep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Kirsehir Ahi Evran Universitesi
- Investigators
- Yusuf Topal, Study chair, Kirsehir Ahi Evran UniversitesiAydin Guclu, Study chair, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696274
- Sponsor's protocol ID
- 2024-12/101
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Kinesiophobia and Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06696274
- Acronym / sponsor ID
- 2024-12/101
- Conditions
- Hemodialysis, End Stage Renal Disease (ESRD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Nov 2024 (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 aim of our study was to investigate the relationship between kinesiophobia and pain, balance, physical performance, quality of life and mental status in patients receiving hemodialysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage renal disease receiving hemodialysis will be enrolled in the study.
Key inclusion criteria (4 listed)
- Patients with end stage renal disease receiving hemodialysis
- Receiving hemodialysis for more than 3 months
- Being clinically stable
- Volunteering to participate in this stud
Key exclusion criteria (1 listed)
- -Having musculoskeletal disorders that may affect physical performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinesiophobia
Time frame: Day 1
It will be evaluated with the Tampa Kinesiophobia scale.The total score ranges from 17-68, with a score above 37 indicating a high degree of kinesiophobia.
Pain
Time frame: Day 1
Will be evaluated with a numeric rating scale. Higher scores indicate worse outcomes.
Balance
Time frame: Day 1
It will be assessed with a timed up and go test
Physical performance
Time frame: Day 1
It will be evaluated with five-repetition sit-to-stand test
3 secondary outcomes
Quality of life
Time frame: Day 1
Mental health
Time frame: Day 1
Comorbidity level
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
Yusuf Topal study chair
Kirsehir Ahi Evran Universitesi
Aydin Guclu study chair
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis and End Stage Renal Disease (ESRD), run by Kirsehir Ahi Evran Universitesi 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Firat (+90 850 441 02 44, mervefirat@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: Day 1). The study lists 4 primary outcomes in all. 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 25 Nov 2024.