The Effects of Clinical Pilates Training in Patients With Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates
Home exercises
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, pilates, postural balance, physical endurance, flexibility
Eligibility Criteria
Inclusion Criteria:
- having AS diagnosis based on modified New York criteria,
- being 20-60 years of age, volunteering to participate in the study,
- having no regular exercise habit in the last 6 months,
- agreeing not to participate in any other type of physical exercise program during the study
Exclusion Criteria:
- not attending 4 consecutive Pilates or home exercise sessions,
- change in medication within the previous 6 months or during the study,
- presence of neurological or coexistent systemic disease, history of orthopedic surgery, and active enthesitis
Sites / Locations
- Dokuz Eylül University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pilates group
Control group
Arm Description
The Pilates group participated in an 8-week clinical Pilates training program
Control group were given a home-based exercise program
Outcomes
Primary Outcome Measures
Bath Ankylosing Sponsylitis Disease Activity Index (BASDAI)
Disease activity was assessed with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It gives a score ranging from 0-10. High score indicates an increase in disease activity.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Functional status was assessed with BASFI. BASFI is comprised of ten items, eight questioning the activities of daily living and two the patient's ability to cope with everyday life. Each is answered on a 10-cm horizontal visual analogue scale (VAS). Total score ranges between 0 and 10, higher scores indicating more severe impairment.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
The Bath Ankylosing Spondylitis Metrology Index (BASMI) was used to assess spinal mobility. BASMI consists of clinical measures of cervical rotation, tragus wall distance, lumbal flexion (modified Schober) and intermalleolar distance.
Ankylosing Spondylitis Quality of Life (ASQoL)
Quality of life was assessed with the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, which is the most frequently used disease-specific measure of health-related quality of life. High scores in this 18-item questionnaire indicate severe impairment in quality of life.
Secondary Outcome Measures
Trunk flexor endurance test
For trunk flexor endurance test, participants lean on a support which kept the trunk at 60° flexion. Both the knees and hips were flexed to 90°, arms crossed over the chest with the hands placed on the opposite shoulder and feet were fixed. The support of the trunk was then removed, and the participant remained in this position for as long as possible. The test ended when the participant was no longer able to hold the position. The position holding time was recorded in seconds.
Trunk extensor endurance test
The extensor endurance test was conducted when the participant lay on the examining table in the prone position with the upper edge of the iliac crests aligned with the edge of the table. The lower body was fixed to the table by two straps, located around the knees and ankles. With the arms folded across the chest, the participant was asked to maintain the upper body in a horizontal position. The time during which the participant could hold this position was recorded in seconds
Side bridge test
The lateral side bridge test was performed in the sidelying position on the mat. The subject's knees were extended with the top foot placed in front of the lower foot. The subject supported their weight only on their lower elbow and feet while lifting their hips off the mat. Upper arm crossed over the chest with hand placed on the opposite shoulder. The test ended when the side-lying position was lost, and the position-holding time was recorded in seconds.
Sit-up test
Sit-up test was used to assess dynamic core endurance.The subject was positioned supine with knees flexed and feet secured. The arms were crossed on the chest with the hands on the opposite shoulders. To complete a full sit-up, the participant's scapulae touched the mat in the lying position, and the elbows touched the thighs while sitting. The number of correctly executed sit-ups within 60 s was recorded.
Balance Assessment
Balance was assessed using the Biodex Balance System SD (Biodex, Inc, Shirley, NY), an instrument designed to measure and train postural stability on a static or unstable surface. . Static postural stability (Level 12, stable platform), dynamic postural stability (Level 4, unstable platform), single-leg stance postural stability (Level 12, stable platform), and limits of stability (LOS) (Level 12, stable platform) tests were performed.
Full Information
NCT ID
NCT04292028
First Posted
February 25, 2020
Last Updated
March 2, 2020
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT04292028
Brief Title
The Effects of Clinical Pilates Training in Patients With Ankylosing Spondylitis
Official Title
The Effects of Clinical Pilates Training on Disease-specific Indices, Core Stability, and Balance in Patients With Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul 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
The objective of this study was to examine the effects of 8-week clinical Pilates training on disease-specific indices, core stability, and balance in ankylosing spondylitis (AS) patients.
Detailed Description
The objective of this study was to examine the effects of 8-week clinical Pilates training on disease-specific indices, core stability, and balance in ankylosing spondylitis (AS) patients. AS patients were randomly assigned to either the Pilates group (PG) or control group (CG). The PG participated in Pilates training 3 times a week for 8 weeks. Patients in the CG were instructed to follow a home exercise program 3 times a week for 8 weeks. Assessments were performed before and after the interventions. Outcome measures were disease-specific indices, core endurance, and balance. Disease-specific indices were: Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Bath AS Spinal Mobility Index (BASMI), and the AS Quality of Life (ASqOL) questionnaire. Static core endurance was assessed with trunk flexor, extensor endurance, and lateral side bridge tests, while dynamic core endurance was assessed using modified sit-up test. Balance was assessed with static, dynamic, and single-leg stance postural stability (PS) and limits of stability (LOS) tests using the Biodex Balance System SD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis, pilates, postural balance, physical endurance, flexibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pilates group
Arm Type
Experimental
Arm Description
The Pilates group participated in an 8-week clinical Pilates training program
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group were given a home-based exercise program
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention Description
The Pilates group participated in an 8-week clinical Pilates training program
Intervention Type
Other
Intervention Name(s)
Home exercises
Intervention Description
Control group were given a home-based exercise program.
Primary Outcome Measure Information:
Title
Bath Ankylosing Sponsylitis Disease Activity Index (BASDAI)
Description
Disease activity was assessed with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It gives a score ranging from 0-10. High score indicates an increase in disease activity.
Time Frame
2 minutes
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
Functional status was assessed with BASFI. BASFI is comprised of ten items, eight questioning the activities of daily living and two the patient's ability to cope with everyday life. Each is answered on a 10-cm horizontal visual analogue scale (VAS). Total score ranges between 0 and 10, higher scores indicating more severe impairment.
Time Frame
4 minutes
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
The Bath Ankylosing Spondylitis Metrology Index (BASMI) was used to assess spinal mobility. BASMI consists of clinical measures of cervical rotation, tragus wall distance, lumbal flexion (modified Schober) and intermalleolar distance.
Time Frame
7 minutes
Title
Ankylosing Spondylitis Quality of Life (ASQoL)
Description
Quality of life was assessed with the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, which is the most frequently used disease-specific measure of health-related quality of life. High scores in this 18-item questionnaire indicate severe impairment in quality of life.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Trunk flexor endurance test
Description
For trunk flexor endurance test, participants lean on a support which kept the trunk at 60° flexion. Both the knees and hips were flexed to 90°, arms crossed over the chest with the hands placed on the opposite shoulder and feet were fixed. The support of the trunk was then removed, and the participant remained in this position for as long as possible. The test ended when the participant was no longer able to hold the position. The position holding time was recorded in seconds.
Time Frame
5 minutes
Title
Trunk extensor endurance test
Description
The extensor endurance test was conducted when the participant lay on the examining table in the prone position with the upper edge of the iliac crests aligned with the edge of the table. The lower body was fixed to the table by two straps, located around the knees and ankles. With the arms folded across the chest, the participant was asked to maintain the upper body in a horizontal position. The time during which the participant could hold this position was recorded in seconds
Time Frame
5 minutes
Title
Side bridge test
Description
The lateral side bridge test was performed in the sidelying position on the mat. The subject's knees were extended with the top foot placed in front of the lower foot. The subject supported their weight only on their lower elbow and feet while lifting their hips off the mat. Upper arm crossed over the chest with hand placed on the opposite shoulder. The test ended when the side-lying position was lost, and the position-holding time was recorded in seconds.
Time Frame
5 minutes
Title
Sit-up test
Description
Sit-up test was used to assess dynamic core endurance.The subject was positioned supine with knees flexed and feet secured. The arms were crossed on the chest with the hands on the opposite shoulders. To complete a full sit-up, the participant's scapulae touched the mat in the lying position, and the elbows touched the thighs while sitting. The number of correctly executed sit-ups within 60 s was recorded.
Time Frame
2 minutes
Title
Balance Assessment
Description
Balance was assessed using the Biodex Balance System SD (Biodex, Inc, Shirley, NY), an instrument designed to measure and train postural stability on a static or unstable surface. . Static postural stability (Level 12, stable platform), dynamic postural stability (Level 4, unstable platform), single-leg stance postural stability (Level 12, stable platform), and limits of stability (LOS) (Level 12, stable platform) tests were performed.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
having AS diagnosis based on modified New York criteria,
being 20-60 years of age, volunteering to participate in the study,
having no regular exercise habit in the last 6 months,
agreeing not to participate in any other type of physical exercise program during the study
Exclusion Criteria:
not attending 4 consecutive Pilates or home exercise sessions,
change in medication within the previous 6 months or during the study,
presence of neurological or coexistent systemic disease, history of orthopedic surgery, and active enthesitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NURSEN İLÇİN
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylül University
City
İzmir
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
35320
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effects of Clinical Pilates Training in Patients With Ankylosing Spondylitis
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