Familial Mediterranean Fever (FMF )NCT06725849
Barriers to Physical Activity in Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever (FMF ), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Familial Mediterranean Fever (FMF )
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2024to 16 Dec 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Diagnosis of Familial Mediterranean Fever (FMF)
- Ability to respond to the questionnaires
- Capability to engage in physical activity
Who cannot join
- Any form of disability (visual, auditory, mental, physical)
- Illiteracy in Turkish
- Presence of comorbidities that may hinder assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fatma Zehra KARAKOC, Bachelor contact
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul
Tugba CIVI KARAASLAN, PhD., +902128663700 ext. 28322, tugba.civi@iuc.edu.tr
Tugba CIVI KARAASLAN
About this study
Official title: Barriers to Physical Activity and Exercise in Patients With Familial Mediterranean Fever
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.
Read the detailed description
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.
- Conditions
- Familial Mediterranean Fever (FMF )
- Keywords
- exercise, Physical Activity
- Medical subject headings
- Familial Mediterranean Fever, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: It will be applied once for up to 6 months.
Secondary outcomes (5)
McGill Melzack Pain Questionnaire
Developed by Melzack and Targerson in 1971, the questionnaire has undergone validity and reliability studies in Turkish by Eti Aslan and Olgun. The questionnaire consists of four subsections. The introductory section inquires about the patient's name, age, medical diagnosis/issues, the type and dosage of analgesics used, and the patient's level of cognition.
The first section asks about the location and type of pain (deep - D / superficial - Y). The second section asks the individual to describe their current pain. The third section examines the relationship of pain with time, consisting of three questions aimed at determining the continuity, frequency, and factors that increase or decrease the pain.
The fourth section assesses the intensity of the pain, with five word groups ranging from mild to unbearable. The total score ranges from 0 to 112.
Measured: It will be applied once for up to 6 months.
Tampa Scale for Kinesiophobia-Fatigue
The original Tampa Scale for Kinesiophobia (TSK) was developed by Miller, Kopri, and Todd in 1991 but was not published. Vlaeyen and colleagues re-published the original scale, consisting of 17 items, in 1995 with the permission of the original developers. The TSK is a 17-item questionnaire designed to measure fear of movement/re-injury. The scale includes parameters related to work-related activities, injury/re-injury, and fear-avoidance.
Vlaeyen and colleagues later created two shorter forms of this scale, each consisting of 13 items. Fear of movement is a significant issue that negatively impacts patients' quality of life, leading to varying degrees of disability and participation problems. It is essential to identify this issue and consider the patients' fears of movement in addition to implementing targeted treatments in treatment programs.
Measured: It will be applied once for up to 6 months.
Fatigue Severity Scale
The scale consists of 9 questions, each with a score ranging from 1 to 7. An increase in the scale score indicates a higher level of fatigue. In 2007, Armutlu and colleagues conducted validity and reliability studies for the scale in Turkey. The scale assesses individuals' fatigue levels over the past month, as studied by Yorulmaz et al. in patients with sleep apnea.
Responses are scored from "Not at all agree (1)" to "Completely agree (7)." The scale score is the average value of the responses. If the average score is 5 or higher, it is evaluated as "fatigue present.
Measured: It will be applied once for up to 6 months.
Digital Hydraulic Hand Dynamometer
Hydraulic devices that use kilograms or pounds as measurement units allow for the measurement of static grip strength. A digital hydraulic hand dynamometer will be used to measure the participants' gross grip strength. Gross grip refers to the grasping motion used to hold an object in the palm of the hand.
During the measurement, the hand is in a pinch grip position, and the metacarpophalangeal joints are in a flexed position. The gripping section of the device can be adjusted to different levels according to the size of the hand. The patient sits in a chair with the shoulder in a neutral position, the elbow flexed at 90 degrees, the forearm resting on the table, and the wrist in a neutral position. The participant is instructed to perform a strong grip.
The measurement is repeated three times, and the average of the three values is recorded in kilograms.
Measured: It will be applied once for up to 6 months.
Aerobic Capacity Assessment: Spirometer
A spirometer is a device used to measure respiratory function.Currently, flow meters are commonly used. The sensors in the device are sensitive to flow, and they calculate volume based on the measured flow. The values provided for the patient are compared to reference data.Flow-type spirometers are easy to clean and disinfect, and the devices must be calibrated daily.The test is performed in a seated position. A clip is placed on the patient's nose, and they are instructed to take a disposable mouthpiece and hold it tightly with their lips. The individual is asked to breathe in and out 4 to 5 times at normal tidal volume through the spirometer mouthpiece. Then, they are instructed to take a deep breath and exhale quickly and forcefully. The exhalation should be continuous for at least 6 seconds. After sufficient exhalation, the individual is instructed to take a deep breath to conclude the test. The test is repeated three times, and the highest value is recorded.
Measured: It will be applied once for up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion16 Dec 2025 (estimated)
- Study completion16 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Civi Karaaslan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725849
- Sponsor's protocol ID
- ISTANBULC6
- Status last verified
- Dec 2024
- First submitted
- 17 Oct 2024
- Last updated
- 10 Dec 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Physical Activity and Exercise in Patients With Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT06725849
- Acronym / sponsor ID
- ISTANBULC6
- Conditions
- Familial Mediterranean Fever (FMF )
- Keywords
- exercise, Physical Activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 16 Dec 2025 (estimated)
- First posted
- 10 Dec 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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Diagnosis of Familial Mediterranean Fever (FMF)
- Ability to respond to the questionnaires
- Capability to engage in physical activity
Key exclusion criteria (3 listed)
- Any form of disability (visual, auditory, mental, physical)
- Illiteracy in Turkish
- Presence of comorbidities that may hinder assessment
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
International Physical Activity Questionnaire Short
Time frame: 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
Time frame: 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.
5 secondary outcomes
McGill Melzack Pain Questionnaire
Time frame: It will be applied once for up to 6 months.
Tampa Scale for Kinesiophobia-Fatigue
Time frame: It will be applied once for up to 6 months.
Fatigue Severity Scale
Time frame: It will be applied once for up to 6 months.
Digital Hydraulic Hand Dynamometer
Time frame: It will be applied once for up to 6 months.
Aerobic Capacity Assessment: Spirometer
Time frame: It will be applied once for up to 6 months.
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 10 Dec 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.
Fatma Zehra KARAKOC, Bachelor contact
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 Familial Mediterranean Fever (FMF ), run by Istanbul University 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Dec 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 Tugba CIVI KARAASLAN, PhD. (+902128663700 ext. 28322, tugba.civi@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire Short (time frame: It will be applied once for up to 6 months.). The study lists 2 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 10 Dec 2024.