NCT06696274

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

November 6, 2024

Last Update Submit

November 22, 2024

Conditions

HemodialysisEnd Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (4)

  • 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.

    Day 1

  • Pain

    Will be evaluated with a numeric rating scale. Higher scores indicate worse outcomes.

    Day 1

  • Balance

    It will be assessed with a timed up and go test

    Day 1

  • Physical performance

    It will be evaluated with five-repetition sit-to-stand test

    Day 1

Secondary Outcomes (3)

  • Quality of life

    Day 1

  • Mental health

    Day 1

  • Comorbidity level

    Day 1

Study Arms (1)

Hemodialysis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end-stage renal disease receiving hemodialysis will be enrolled in the study.

You may qualify if:

  • Patients with end stage renal disease receiving hemodialysis
  • Receiving hemodialysis for more than 3 months
  • Being clinically stable
  • Volunteering to participate in this stud

You may not qualify if:

  • Having musculoskeletal disorders that may affect physical performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yusuf Topal

    Kirsehir Ahi Evran University

    STUDY CHAIR

  • Aydin Guclu

    Kirsehir Ahi Evran University

    STUDY CHAIR

Central Study Contacts

Merve Firat

CONTACT

+90 850 441 02 44mervefirat@ahievran.edu.tr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 20, 2024

Study Start

November 18, 2024

Primary Completion

September 1, 2025

Study Completion

January 1, 2026

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

TU(1)