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临床试验/NCT06725849
NCT06725849尚未招募不适用

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

Istanbul University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
International Physical Activity Questionnaire Short

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

International Physical Activity Questionnaire Short

时间窗: It will be applied once for up to 6 months.

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).

Familial Mediterranean Fever Quality of Life Scale

时间窗: It will be applied once for up to 6 months.

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.

次要结局

  • Aerobic Capacity Assessment: Spirometer(It will be applied once for up to 6 months.)
  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tugba Civi Karaaslan

PhD.

Istanbul University - Cerrahpasa

研究点 (1)

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