Barriers to Physical Activity in Familial Mediterranean Fever

NCT06725849 | Not Yet Recruiting

• 1 other identifier: ISTANBULC6
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Familial Mediterranean Fever (FMF )

Keywords

exercise; Physical Activity

Outcome Measures

Primary Outcomes (2)

• International Physical Activity Questionnaire Short

  Prepared with the support of the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), this standardized questionnaire has been developed by researchers from different countries. The questionnaire has both long and short forms. We will evaluate our participants using the short form consisting of 7 items. Sağlam et al. have conducted validity and reliability studies for the Turkish version of the questionnaire. The survey inquires about the time spent on physical activities over the past 7 days. It consists of 7 questions. Questions 1 and 2 ask about the time spent on vigorous physical activities, specifically how many days per week and how many minutes (or hours) per day. Questions 3 and 4 focus on moderate-intensity activities, while questions 5 and 6 inquire about the time spent walking, asking how many days per week and how many minutes (or hours) per day. The last question asks about the time spent sitting, inquiring how many minutes (or hours).

  It will be applied once for up to 6 months.

• Familial Mediterranean Fever Quality of Life Scale

  Developed with the support of the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) by researchers from different countries, the scale consists of 20 questions and is based on four factors, developed using psychometric methods. The factor groups represent four different dimensions related to quality of life in Familial Mediterranean Fever. Factor 1 is associated with physical impact, Factor 2 with social and recreational impact, Factor 3 with psychological impact, and Factor 4 with the impact of sleep.The FMF Quality of Life (FMF QL) scale has a strong relationship with other generic quality of life questionnaires (such as SF-36 and EUROHIS) and a moderate relationship with disability, sleep, and depression scales that may be related to quality of life. The relationships of the questionnaire with parameters not directly related to quality of life are weak to moderate or nonsensical, which demonstrates the distinctive feature of our questionnaire.

  It will be applied once for up to 6 months.

Secondary Outcomes (5)

• McGill Melzack Pain Questionnaire

  It will be applied once for up to 6 months.

• Tampa Scale for Kinesiophobia-Fatigue

  It will be applied once for up to 6 months.

• Fatigue Severity Scale

  It will be applied once for up to 6 months.

• Digital Hydraulic Hand Dynamometer

  It will be applied once for up to 6 months.

• Aerobic Capacity Assessment: Spirometer

  It will be applied once for up to 6 months.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Mediterranean Fever; Motor Activity

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Tugba CIVI KARAASLAN, PhD.

CONTACT

+902128663700; tugba.civi@iuc.edu.tr

Fatma Zehra KARAKOC, Bachelor

CONTACT

zehrakarakoc51@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: December 10, 2024
• Study Start: December 16, 2024
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

TU (1)