ClinicalTrials.gov record NCT06725849

Barriers to Physical Activity in Familial Mediterranean Fever

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Barriers to Physical Activity and Exercise in Patients With Familial Mediterranean Fever

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 65 years old
SexAll
LocationTurkey
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study looks for reasons patients with Familial Mediterranean Fever (FMF) avoid or have trouble with physical activity. Participants will complete questionnaires on activity, pain, quality of life, fatigue, and fear of movement. They will also have supervised grip-strength and breathing (spirometry) measurements done twice weekly for three months (30‑minute sessions).

What it is studying. The study is trying to identify the problems and reasons FMF patients experience when attempting physical activity. To do this it assesses self-reported physical activity, pain, quality of life, fatigue, and fear of movement, alongside objective measures of grip strength and respiratory/aerobic function.

What the researchers hope to learn. Scientifically, the study aims to identify and describe barriers to physical activity in people with FMF by measuring pain, fatigue, fear of movement (kinesiophobia), quality of life, grip strength, and aerobic capacity. The goal is to better understand factors associated with avoidance of physical activity in this population.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This project is a 2209-A TÜBİTAK project. It has been developed to identify the barriers to physical activity among patients diagnosed with Familial Mediterranean Fever (FMF). The project aims to determine the problems encountered by FMF patients when engaging in physical activity and the reasons behind these issues, using various assessment methods to identify the reasons for avoiding physical activity.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Diagnosis of Familial Mediterranean Fever (FMF)
  • Ability to respond to the questionnaires
  • Capability to engage in physical activity

Exclusion criteria

  • Any form of disability (visual, auditory, mental, physical)
  • Illiteracy in Turkish
  • Presence of comorbidities that may hinder assessment

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This project is a 2209-A TÜBİTAK project. It has been developed to identify the barriers to physical activity among patients diagnosed with Familial Mediterranean Fever (FMF) referred to the Department of Internal Medicine, Rheumatology Division, at Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty, as well as the Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. The project aims to determine the problems encountered by FMF patients when engaging in physical activity and the reasons behind these issues, using various assessment methods to identify the reasons for avoiding physical activity. Patients diagnosed with FMF will be evaluated based on pain (McGill Melzack Pain Questionnaire), quality of life (FMF Quality of Life Measure), fatigue status (Fatigue Severity Scale), kinesiophobia (Tampa Scale for Kinesiophobia), grip strength (Digital Hydraulic Hand Dynamometer), and aerobic capacity (Spirometer). Assessments will be conducted twice a week for three months, with each session lasting 30 minutes, utilizing the Digital Hydraulic Hand Dynamometer and Spirometer under the supervision of researchers.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Taking part involves completing several questionnaires about physical activity, quality of life, pain, fatigue, and fear of movement (the registry lists the International Physical Activity Questionnaire—short form; FMF Quality of Life Scale; McGill Pain Questionnaire; Fatigue Severity Scale; and Tampa Scale for Kinesiophobia). Participants will also attend supervised measurement sessions twice a week for three months, each about 30 minutes, to record grip strength with a digital hydraulic hand dynamometer and to measure breathing/lung function with a spirometer. Grip strength is measured by three squeezes with the average recorded; spirometry uses a nose clip and disposable mouthpiece with several breaths and up to three forced exhalations, recording the best result. Some questionnaires are noted as being applied once within a period of up to six months; the record lists these supervised tests and questionnaires but does not list any invasive procedures.

How the study is structured. This is an observational, case-only, cross-sectional study. Participants will complete several questionnaires (applied once within the study period) and undergo supervised physical tests: grip-strength and spirometry measurements performed twice a week for three months in 30‑minute sessions.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Turkey. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Important dates

Study start
Dec 16, 2024 (estimated)
Primary completion
Dec 16, 2025 (estimated)
Study completion
Dec 16, 2025 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Dec 10, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Istanbul University
Principal investigator
Tugba Civi Karaaslan, PhD.
Istanbul University - Cerrahpasa

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Istanbul University-Cerrahpasa

    Istanbul · Turkey (Türkiye)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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