The Effects of Clinical Pilates Training in Patients With Ankylosing Spondylitis

• ClinicalTrials.gov Identifier: NCT04292028
• Recruitment Status: Completed
• First Posted: March 2, 2020
• Last Update Posted: March 3, 2020
• Sponsor: Dokuz Eylul University
• Information provided by (Responsible Party): Yasemin ACAR, Dokuz Eylul University

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.

Condition or disease	Intervention/treatment	Phase
Ankylosing Spondylitis	Other: Pilates; Other: Home exercises	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effects of Clinical Pilates Training on Disease-specific Indices, Core Stability, and Balance in Patients With Ankylosing Spondylitis
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: June 1, 2018
• Actual Study Completion Date: June 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: pilates group; The Pilates group participated in an 8-week clinical Pilates training program	Other: Pilates; The Pilates group participated in an 8-week clinical Pilates training program
Active Comparator: Control group; Control group were given a home-based exercise program	Other: Home exercises; Control group were given a home-based exercise program.

Outcome Measures

Primary Outcome Measures :

1. Bath Ankylosing Sponsylitis Disease Activity Index (BASDAI) [ Time Frame: 2 minutes ]
   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. Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: 4 minutes ]
   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.
3. Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: 7 minutes ]
   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.
4. Ankylosing Spondylitis Quality of Life (ASQoL) [ Time Frame: 3 minutes ]
   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 :

1. Trunk flexor endurance test [ Time Frame: 5 minutes ]
   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.
2. Trunk extensor endurance test [ Time Frame: 5 minutes ]
   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
3. Side bridge test [ Time Frame: 5 minutes ]
   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.
4. Sit-up test [ Time Frame: 2 minutes ]
   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.
5. Balance Assessment [ Time Frame: 10 minutes ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Dokuz Eylül University

İzmir, Eyalet/Yerleşke, Turkey, 35320

Sponsors and Collaborators

Dokuz Eylul University

Investigators

• Study Director: NURSEN İLÇİN; Dokuz Eylul University

More Information

• Responsible Party: Yasemin ACAR, Research assistant, Dokuz Eylul University
• ClinicalTrials.gov Identifier: NCT04292028
• Other Study ID Numbers: 2017/07-33
• First Posted: March 2, 2020
• Last Update Posted: March 3, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Keywords provided by Yasemin ACAR, Dokuz Eylul University:

ankylosing spondylitis; pilates; postural balance; physical endurance; flexibility

Additional relevant MeSH terms:

Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis