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

Primary Purpose

Behcet Disease, FMF

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pilates exercise
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IstanbulU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

behcet group

fmf group

healty control

Arm Description

this group includes 16 patients with behçet

this group includes 16 patients with fmf

this group includes 16 healthy control

Outcomes

Primary Outcome Measures

international physical activity questionnaire- short form Web sonuçları International Physical Activity Questionnaire - Short Form
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.
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.
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

Secondary Outcome Measures

Berg Balance Scale (BBS)
The BBS is a 14- item balance test recognized as the gold standard tool for assessing balance (higher scores indicate better balance)
Hamilton Depression Scale
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.
Nottingham Health Profile Questionnaire (NHP)
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

Full Information

First Posted
May 17, 2020
Last Updated
May 22, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04402255
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet Disease, FMF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
behcet group
Arm Type
Experimental
Arm Description
this group includes 16 patients with behçet
Arm Title
fmf group
Arm Type
Experimental
Arm Description
this group includes 16 patients with fmf
Arm Title
healty control
Arm Type
Active Comparator
Arm Description
this group includes 16 healthy control
Intervention Type
Other
Intervention Name(s)
pilates exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
international physical activity questionnaire- short form Web sonuçları International Physical Activity Questionnaire - Short Form
Description
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.
Time Frame
change from baseline to 8 weeks, follow up at two months
Title
six minute walk test
Description
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.
Time Frame
change from baseline to 8 weeks, follow up at two months
Title
Biodex balance system (BBS)
Description
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
Time Frame
change from baseline to 8 weeks, follow up at two months
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
The BBS is a 14- item balance test recognized as the gold standard tool for assessing balance (higher scores indicate better balance)
Time Frame
change from baseline to 8 weeks, follow up at two months
Title
Hamilton Depression Scale
Description
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.
Time Frame
change from baseline to 8 weeks, follow up at two months
Title
Nottingham Health Profile Questionnaire (NHP)
Description
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
Time Frame
change from baseline to 8 weeks, follow up at two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
IstanbulU
City
Istanbul
State/Province
Bakırköy
ZIP/Postal Code
34740
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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