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Pilates in Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being in the age range of 20-65, using stable medication for at least 3 months, being sedentary (Not regularly participating in exercise activities for the past 3 months). Exclusion Criteria: the presence of cardiovascular, pulmonary, orthopedic and neurological problems, another rheumatic disease, being pregnant, inability to participate in at least 75% of the exercises.

Sites / Locations

  • Usak University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mat Pilates

Reformer Pilates

Arm Description

Mat Pilates Exercises

Reformer Pilates Exercises

Outcomes

Primary Outcome Measures

Bath Ankylosing Spondylitis Metrology Index
This index consists of 5 measurements: cervical rotation, tragus to wall distance, lumbar side flexion, modified Schober's, intermalleolar distance.
Bath Ankylosing Spondylitis Disease Activity Index
BASDAI consists of 6 questions evaluating the patient's level of weakness/fatigue, spinal pain, joint pain/swelling and sensitivity to touch, and duration of morning stiffness in the last week.
Bath Ankylosing Spondylitis Functional Index (BASFI)
This scale, which evaluates the functional limitation of AS patients in activities of daily living, consists of 10 questions.
Ankylosing Spondylitis Quality of Life Questionnaire
This questionnaire, which evaluates disease-specific quality of life, consists of 18 questions
Maastrich Ankylosing Spondylitis Enthesitis Score
Its validity and reliability were defined to evaluate enthesopathy and peripheral joint involvement.
Multidimensional Assessment of Fatigue Scale
MAF scale evaluates the level of fatigue during daily activities in the last week.
Biopsychosocial Questionnaire (BETY-BQ)
The BETY-BQ evaluates the biopsychosocial status of patients with rheumatic diseases.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2023
Last Updated
August 13, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05987111
Brief Title
Pilates in Ankylosing Spondylitis
Official Title
Comparison of Efficacy of Two Different Pilates Exercise Methods in Individuals With Ankylosing Spondylitis: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This study was planned to examine and compare the effectiveness of two different pilates exercise methods (mat pilates vs reformer pilates) in individuals with Ankylosing Spondylitis(AS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mat Pilates
Arm Type
Active Comparator
Arm Description
Mat Pilates Exercises
Arm Title
Reformer Pilates
Arm Type
Experimental
Arm Description
Reformer Pilates Exercises
Intervention Type
Behavioral
Intervention Name(s)
Pilates
Intervention Description
Pilates exercises were applied twice a week for 4 weeks in both groups. The sessions were supervised by an Australian Physiotherapy and Pilates Institute (APPI) certified physiotherapist as 5 minutes of warm-up, 45 minutes of exercise and 5 minutes of cool-down periods.
Primary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Metrology Index
Description
This index consists of 5 measurements: cervical rotation, tragus to wall distance, lumbar side flexion, modified Schober's, intermalleolar distance.
Time Frame
10 minutes
Title
Bath Ankylosing Spondylitis Disease Activity Index
Description
BASDAI consists of 6 questions evaluating the patient's level of weakness/fatigue, spinal pain, joint pain/swelling and sensitivity to touch, and duration of morning stiffness in the last week.
Time Frame
5minutes
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
This scale, which evaluates the functional limitation of AS patients in activities of daily living, consists of 10 questions.
Time Frame
5 minutes
Title
Ankylosing Spondylitis Quality of Life Questionnaire
Description
This questionnaire, which evaluates disease-specific quality of life, consists of 18 questions
Time Frame
5 minutes
Title
Maastrich Ankylosing Spondylitis Enthesitis Score
Description
Its validity and reliability were defined to evaluate enthesopathy and peripheral joint involvement.
Time Frame
5minutes
Title
Multidimensional Assessment of Fatigue Scale
Description
MAF scale evaluates the level of fatigue during daily activities in the last week.
Time Frame
5 minutes
Title
Biopsychosocial Questionnaire (BETY-BQ)
Description
The BETY-BQ evaluates the biopsychosocial status of patients with rheumatic diseases.
Time Frame
10minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being in the age range of 20-65, using stable medication for at least 3 months, being sedentary (Not regularly participating in exercise activities for the past 3 months). Exclusion Criteria: the presence of cardiovascular, pulmonary, orthopedic and neurological problems, another rheumatic disease, being pregnant, inability to participate in at least 75% of the exercises.
Facility Information:
Facility Name
Usak University
City
Usak
State/Province
Merkez
ZIP/Postal Code
64200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilates in Ankylosing Spondylitis

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