- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04402255
Pilates Based Exercises in Patients With Behçet and Familial Mediterranean Fever.
May 22, 2020 updated by: Nejla Uzun, Istanbul University
The Effect of Pilates Based Exercise Practice on Physical and Psychological Parameters in Patients With Behçet and Familial Mediterranean Fever.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bakırköy
-
Istanbul, Bakırköy, Turkey, 34740
- IstanbulU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: behcet group
this group includes 16 patients with behçet
|
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.
|
EXPERIMENTAL: fmf group
this group includes 16 patients with fmf
|
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.
|
ACTIVE_COMPARATOR: healty control
this group includes 16 healthy control
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
international physical activity questionnaire- short form Web sonuçları International Physical Activity Questionnaire - Short Form
Time Frame: change from baseline to 8 weeks, follow up at two months
|
This short questionnaire, consisting of seven questions, evaluates the amount of walking done in the last week and the amount of moderate and difficult physical activities performed in work, transportation, housework, gardening and leisure activities.
|
change from baseline to 8 weeks, follow up at two months
|
six minute walk test
Time Frame: change from baseline to 8 weeks, follow up at two months
|
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)
Time Frame: change from baseline to 8 weeks, follow up at two months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale (BBS)
Time Frame: change from baseline to 8 weeks, follow up at two months
|
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
|
Hamilton Depression Scale
Time Frame: change from baseline to 8 weeks, follow up at two months
|
The scale was prepared as 21 items, but the last four items were not included in the scoring.
The total score is determined on 17 items.
|
change from baseline to 8 weeks, follow up at two months
|
Nottingham Health Profile Questionnaire (NHP)
Time Frame: change from baseline to 8 weeks, follow up at two months
|
NHP were used as research tools.
The Nottingham Health Profile Questionnaire was used to measure health problems perceived by the patient and to assess the effect of these problems on daily functioning
|
change from baseline to 8 weeks, follow up at two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2019
Primary Completion (ACTUAL)
April 30, 2020
Study Completion (ANTICIPATED)
December 30, 2020
Study Registration Dates
First Submitted
May 17, 2020
First Submitted That Met QC Criteria
May 22, 2020
First Posted (ACTUAL)
May 26, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 26, 2020
Last Update Submitted That Met QC Criteria
May 22, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Infections
- Eye Diseases
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Mouth Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Vasculitis
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Behcet Syndrome
- Brucellosis
- Familial Mediterranean Fever
- Hereditary Autoinflammatory Diseases
Other Study ID Numbers
- 83088843-604.01.04-5578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on FMF
-
Sheba Medical CenterUnknownFMF | Colchicine Resistance | Colchicine ToxicityIsrael
-
Rambam Health Care CampusWithdrawnFamilial Mediterranean Fever (FMF )
-
Assistance Publique - Hôpitaux de ParisInstitut ImagineNot yet recruitingAutoinflammatory Disease | FMF | TRAPS | MKD | Cryopyrin Associated Periodic Syndrome | HaploinsufficiencyFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
Istanbul University - Cerrahpasa (IUC)Recruiting
-
R-Pharm International, LLCAtlant Clinical LLC; Center for Pharmaceutical Analytics LLC; Unimed Laboratories... and other collaboratorsRecruitingFamilial Mediterranean Fever | FMFArmenia, Georgia, Russian Federation
-
R-Pharm International, LLCR-Pharm; Atlant Clinical LLC; Unimed Laboratories CJSC; Data Management 365; Center...RecruitingFamilial Mediterranean Fever | FMFArmenia, Georgia, Russian Federation
-
University of PalermoCompletedFamilial Mediterranean Fever (FMF) | Not-celiac Wheat Sensitivity (NCWS)Italy
Clinical Trials on pilates exercise
-
Universidad de AntioquiaCompletedHealthy VolunteersColombia
-
Gazi UniversityUnknownRheumatoid ArthritisTurkey
-
Saglik Bilimleri UniversitesiCompleted
-
National University of Ireland, Galway, IrelandCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Completed
-
Universidade Federal de Santa MariaCompleted
-
Eastern Mediterranean UniversityCompleted
-
Paulista UniversityCompleted
-
Eastern Mediterranean UniversityUnknownThe Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'Osteo Arthritis Knee | BalanceCyprus
-
Universidade Federal do Triangulo MineiroCompleted
-
Istanbul Medipol University HospitalCompleted