Ankylosing Spondylitis Clinical Trial
Official title:
The Effects of Clinical Pilates Training on Disease-specific Indices, Core Stability, and Balance in Patients With Ankylosing Spondylitis
NCT number | NCT04292028 |
Other study ID # | 2017/07-33 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | June 1, 2018 |
Verified date | March 2020 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylül University | Izmir | Eyalet/Yerleske |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 minutes | |
Primary | 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. | 4 minutes | |
Primary | 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. | 7 minutes | |
Primary | 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. | 3 minutes | |
Secondary | 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. | 5 minutes | |
Secondary | 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 | 5 minutes | |
Secondary | 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. | 5 minutes | |
Secondary | 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. | 2 minutes | |
Secondary | 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. | 10 minutes |
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