Pilates Based Exercises in Patients With Behçet and Familial Mediterranean Fever.

NCT04402255 | Completed

• 1 other identifier: 83088843-604.01.04-5578
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet Disease; FMF

Outcome Measures

Primary Outcomes (3)

• Berg Balance Scale (BBS) Web sonuçları International Physical Activity Questionnaire - Short Form

  The BBS is a 14- item balance test recognized as the gold standard tool for assessing balance (higher scores indicate better balance)

  change from baseline to 8 weeks, follow up at two months

• six minute walk test

  It is a simple test that measures the distance an individual can walk at a fast pace on a flat, hard floor in 6 minutes.

  change from baseline to 8 weeks, follow up at two months

• Biodex balance system (BBS)

  The BBS has a round foot platform that moves in all planes. It grants 20 degrees of foot platform motion in different directions. The platform has foot angles and heel coordinates for proper foot placement before starting the balance test trial. The foot angles range from 0° to 45° and heel coordinates are expressed as the intersection of letters from A to P and numbers from 1 to 21. The participants were asked to centralize their body while they placed their feet in the most comfortable position and their feet 10 cm apart with eyes open. They were asked to hold the rails in case they felt unbalanced. The machine measured the magnitude of their postural sways: higher scores for postural sway indicate impaired balance, and a lower score indicate excellent balance

  change from baseline to 8 weeks, follow up at two months

Secondary Outcomes (3)

• international physical activity questionnaire- short form

  change from baseline to 8 weeks, follow up at two months

• Hamilton Depression Scale

  change from baseline to 8 weeks, follow up at two months

• Nottingham Health Profile Questionnaire (NHP)

  change from baseline to 8 weeks, follow up at two months

Study Arms (3)

behcet group

EXPERIMENTAL

this group includes 16 patients with behçet

Other: pilates exercise

fmf group

EXPERIMENTAL

this group includes 16 patients with fmf

Other: pilates exercise

healty control

ACTIVE COMPARATOR

this group includes 16 healthy control

Other: pilates exercise

Interventions

pilates exercise OTHER

The key elements of Pilates during supine, prone, side-lying and standing positions will be taught. These key elements are: breathing (diaphragmatic), focusing (neutral position), rib cage placement, shoulder placement, head and neck placement (neutral position). Then, Pilates based 'mat' exercises will be performed by the physiotherapist in the clinic for 8 weeks, 2 days / week, 16 sessions. Each session will be programmed to be 45 minutes. During all exercises, including warm-up and cooling, patients will be asked to provide key elements and protect them during movements. Depending on the condition of the patients, the exercises will be advanced from easy to difficult.

behcet group; fmf group; healty control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

IstanbulU

Istanbul, Bakırköy, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Pt

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 26, 2020
• Study Start: June 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: December 30, 2021
• Last Updated: February 5, 2025

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)