CClinicalTrials.gg
CompletedNCT04292028Updated Mar 3, 2020

The Effects of Clinical Pilates Training in Patients With Ankylosing Spondylitis

An interventional study of Pilates and Home exercises in Ankylosing Spondylitis, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jun 2017, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • ankylosing spondylitis
  • pilates
  • postural balance
  • physical endurance
  • flexibility
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 60 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    pilates group

    The Pilates group participated in an 8-week clinical Pilates training program

    Other: Pilates

  • Active comparator
    Control group

    Control group were given a home-based exercise program

    Other: Home exercises

Interventions

  • OtherPilates

    The Pilates group participated in an 8-week clinical Pilates training program

  • OtherHome exercises

    Control group were given a home-based exercise program.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 minutes

  2. 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.

    Time frame: 4 minutes

  3. 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.

    Time frame: 7 minutes

  4. 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.

    Time frame: 3 minutes

Secondary outcomes

  1. 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.

    Time frame: 5 minutes

  2. 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

    Time frame: 5 minutes

  3. 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.

    Time frame: 5 minutes

  4. 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.

    Time frame: 2 minutes

  5. 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.

    Time frame: 10 minutes

07

Study locations

1 site
  • Dokuz Eylül University
    İzmir, Eyalet/Yerleşke 35320, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04292028
Lead sponsor
Dokuz Eylul University
Responsible party
Yasemin ACAR (Research assistant, Dokuz Eylul University) — Principal investigator
First posted
Mar 2, 2020
Start date
Jun 1, 2017
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Mar 3, 2020

Study contacts

NURSEN İLÇİN
study director · Dokuz Eylul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion