Clinical trial NCT04402255: Pilates Based Exercises in Patients With Behçet and Familial Mediterranean Fever.
Official title: The Effect of Pilates Based Exercise Practice on Physical and Psychological Parameters in Patients With Behçet and Familial Mediterranean Fever.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behcet Disease
FMF
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Behcet's disease (BD) is a chronic systemic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthritis, arthralgia, enthesitis and sacroiliitis can be seen in the course of BD. Familial Mediterranean fever (FMF) is the most frequent autoinflammatory disease (AID) and characterized by selflimited episodes of fever and polyserositis. It is the most common monogenic periodic fever syndrome that affects mainly the people of Mediterranean descent. Regular physical activity involving aerobic and strengthening programs in inflammatory rheumatic diseases has a long-term anti-inflammatory effect. Eccentric exercises cause an acute increase in TNF alpha level and should be avoided especially at the beginning. It has been stated that patients should be encouraged about aerobic exercise programs where the intensity is gradually increased, starting with low intensity. Pilates method is the mind and body centering technique developed by Joseph Hubertus Pilates, based on providing lumbopelvic stability. FMF and BH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. When we look at the literature, there is no study on the effectiveness of exercise applications in FMF and Behçet patients. The purpose of our study; It is the comparison of the effectiveness of physical activity in patients diagnosed with Behçet and FMF and healthy individuals. In this context, with the short form of the International Physical Activity Evaluation Questionnaire, Behçet's patients whose physical activity level is inactive will be Group 1, FMF patients Group 2 and healthy controls with similar demographic characteristics will be Group 3. Pilates based exercise program will be applied to all 3 groups for 8 weeks, 2 times a week.


Eligibility criteria: Inclusion Criteria:

* Being inactive or minimally active according to the International Physical Activity Survey
* Being between the ages of 18-65
* Being diagnosed with FMF at least 1 year ago according to diagnostic criteria
* A diagnosis of BH at least 1 year ago according to the International Behçet Working Group
* Having a cooperative level that can adapt to the evaluation and exercise program

Exclusion Criteria:

* Those with any central nervous system involvement that may interfere with exercise
* Those who do not want to participate in the study
* Pregnant women
* Having other chronic diseases
* Psychiatric disorders and treated
* Those with cognitive impairment

Primary outcomes:
measure: Berg Balance Scale (BBS) Web sonuçları International Physical Activity Questionnaire - Short Form
timeFrame: change from baseline to 8 weeks, follow up at two months
measure: six minute walk test
timeFrame: change from baseline to 8 weeks, follow up at two months
measure: Biodex balance system (BBS)
timeFrame: change from baseline to 8 weeks, follow up at two months
Secondary outcomes:
measure: international physical activity questionnaire- short form
timeFrame: change from baseline to 8 weeks, follow up at two months
measure: Hamilton Depression Scale
timeFrame: change from baseline to 8 weeks, follow up at two months
measure: Nottingham Health Profile Questionnaire (NHP)
timeFrame: change from baseline to 8 weeks, follow up at two months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: IstanbulU
state: Bakırköy
Study officials:
References: