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Ankylosing SpondylitisNCT04292028

The Effects of Clinical Pilates Training in Patients With Ankylosing Spondylitis

A study testing Pilates and Home exercises in people with Ankylosing Spondylitis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Pilates and Home exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Dokuz Eylül University

    Izmir, Eyalet/Yerleşke, 35320

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Clinical Pilates Training on Disease-specific Indices, Core Stability, and Balance in Patients With Ankylosing Spondylitis

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.

Being tested
Pilates, Home exercises
Keywords
ankylosing spondylitis, pilates, postural balance, physical endurance, flexibility
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PilatesOther

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

  • Home exercisesOther

    Control group were given a home-based exercise program.

Study groups in NCT04292028
Study groupRoleWhat they receive
pilates groupExperimentalThe Pilates group participated in an 8-week clinical Pilates training program
Receives: Other: Pilates
Control groupActive comparatorControl group were given a home-based exercise program
Receives: Other: Home exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 3 minutes

Secondary outcomes (5)

  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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start1 Jun 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292028
Sponsor's protocol ID
2017/07-33
Status last verified
Mar 2020
First submitted
25 Feb 2020
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Acar Y, Ilcin N, Gurpinar B, Can G. The effects of clinical pilates training on disease-specific indices, core stability, and balance in patients with ankylosing spondylitis. J Bodyw Mov Ther. 2023 Jan;33:69-75. doi: 10.1016/j.jbmt.2022.09.010. Epub 2022 Sep 23.

    PubMed 36775528

Questions about this trial

What is this clinical trial studying?

A study testing Pilates and Home exercises in people with Ankylosing Spondylitis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bath Ankylosing Sponsylitis Disease Activity Index (BASDAI) (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292028, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

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