CClinicalTrials.gg
Status unknownNCT03904953Updated Apr 9, 2019

Effects of Pilates Training on Respiratory Muscle Strenght in Patients With Ankylosing Spondylitis

An interventional study of Pilates Training and Conventional exercise programme in Ankylosing Spondylitis, sponsored by Gazi University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-04-09.

Sponsored by Gazi University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Background: Ankylosing Spondylitis (AS) is a chronic, inflammatory rheumatic disease that effects primarily axial-spine. Reduction of flexibility and mobility is important factors that can cause muscle weakness, impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of AS. The purpose of this study is to investigate the effects of pilates exercises on mobility, quality of life and respiratory muscle strength in patients with AS.

Methods: Forty patients will be included who are aged between 18-55 years and got diagnosed according to Modified New York criterias.Patients will be divided into two groups randomly. Pilates training will be performed to the treatment group and conventional exercises will be performed to the control group during 8 weeks. Respiratory muscle strength, quality of life, spinal mobility, thorax expansion, respiratory functions, physical activity level, exercise capasity and disease activity will be evaluated at first session and at the end of the 8th week in this study.

Read the detailed description

Objective: Ankylosing Spondylitis (AS) is a chronic, inflammatory rheumatic disease that effects primarily axial-spine. With progression of disease, flexibility of thorax and spine will be get lost. It is reported that mobility, function, respiratory muscle strength and endurance get worse in AS patients. Reduction of flexibility and mobility is important factors that can cause muscle weakness, impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of AS. To writer's knowledge, there has been no study examining the effects of pilates exercises on mobility, function and respiratory muscle strength in AS patients. The purpose of this study is to investigate the effects of pilates exercises on mobility, function and respiratory muscle strength in patients with AS.

Methods: Forty patients were included who are aged between 18-65 years and got diagnosed according to Modified New York criterias. Patients who have incooperation, malignancy and pregnancy will be excluded from the study. Patients will be divided into two groups randomly. Pilates training will be performed to the treatment group and conventional exercises will be performed to the control group during 8 weeks Respiratory muscle strength will be assessed by maximal inspiratory and expiratory pressures. Thorax expansion will be measured from regions of axillar, subcostal and epigastric by tape measure. To evaluate disease activity and spinal mobility, we will use Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Metrology Index (BASMI), respectively. Quality of life will be evaluated with Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). Exercise capacity will be assessed by 6 minutes walk test. Pilates exercises will be performed 3 days in a week for 8 weeks. Conventional exercise programme will be taugt to the control group and requested to perform them at home. The assessments will be repeated in before and after treatment.

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Conditions studied

  • Ankylosing Spondylitis

Keywords

  • Ankylosing Spondylitis
  • Pilates
  • Respiratory muscle strenght
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In context

Spondylitis

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

This study's planned enrollment of 40 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are aged between 18-55 years,
  • Patients who got diagnosed according to Modified New York criteria
  • Patients who are being followed at Gazi University Department of Rheumatology.

Exclusion criteria

Exclusion Criteria:

  • Patients who have exercise habits
  • Incooperation
  • Malignancy
  • Pregnancy
  • Patients who have changes of medical treatment in the last 3 months
  • Patients who have another disease that can effect pulmonary functions
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Study group

    Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

    Other: Pilates Training

  • Active comparator
    Control group

    Stretching of erector spine, hip flexors, hamstring muscles and gastro-soleus muscles; back-strengthening of cervical, thoracic and lumbar spine and posture exercises will be taught to the patients in the first session and the patients will be requested to repeat the exercises three times a week for 8 weeks individually at home.

    Other: Conventional exercise programme

Interventions

  • OtherPilates Training

    Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

  • OtherConventional exercise programme

    Stretching of erector spine, hip flexors, hamstring muscles and gastro-soleus muscles; back-strengthening of cervical, thoracic and lumbar spine and posture exercises will be taught to the patients in the first session and the patients will be requested to repeat the exercises three times a week for 8 weeks individually at home.

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What researchers measure

Primary outcomes

  1. Respiratory muscle strength

    Respiratory muscle strength will be assessed by digital mouth-pressure meter (Micro Medical MicroRM, Rochester, England). Maksimal inspiratory pressure (MIP) and Maksimal Expiratory Pressure (MEP) will be measured with the subject sitting and breathing through a mouthpiece by encouraged verbally, after clamping the nose (cmH2O). To measure MIP, the patient will be requested to breath in quickly and deeply until total lung capacity, just after breath out maximally until residual volume. To measure MEP, the patient will be requested to breath until total lung capacity and then breath out quickly until residual volume. Leaks around the mouthpiece will be avoided. The best of five attempts will be selected and stated as percent of expected values according to sex and age

    Time frame: 5 minutes

Secondary outcomes

  1. Bath Ankylosing Spondylitis Metrology Index

    Spinal mobility will assessed and scored by Bath Ankylosing Spondylitis Metrology Index (BASMI). There are five measurements including lateral lumbar flexion, tragus-to-wall distance, lumbar flexion (Modified Schober), maximal intermalleolar distance and cervical rotation according to the index. Each subscale is scored between 0 and 10. All points are then averaged to calculate total score. Higher values represent worse outcomes.

    Time frame: 5 minutes

  2. Ankylosing Spondylitis Quality of Life Questionnaire

    Quality of life will be assessed with Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) which has 18 items, each with response True/Not True. 'True responses are summed to create a total score. High scores mean poor quality of life

    Time frame: 1 minute

  3. Thorax pain

    Visual Analog Scale (VAS) will be used to determine the intensity of thorax pain; 0 means 'no pain' while 10 means 'unbearable pain'.

    Time frame: 1 minute

  4. Chest expansion

    Chest expansion will be measured with a tape placed circumferentially around the chest wall (axillar, subcostal, epigastric) in cm.

    Time frame: 2 minutes

  5. Aerobic capacity

    Aerobic capacity will be assessed with 6 minute walk test (6MWT) which is a submaximal effort test. 6MWT is a distance required to fast-paced walk on flat floor in length 30 meters. The aim of the 6MWT is to walk as long as the patient can walk in 6 minutes. Dyspnoea and fatigue level are recorded at the end of the test. Distance covered by the patient is calculated at the of 6 minutes

    Time frame: 10 minutes

  6. Bath Ankylosing Spondylitis Disease Activity Index

    Bath Ankylosing Spondylitis Disease Activity Index which consists of 6 questions will be used to evaluate disease activity. BASDAI is a composite index, consisting of an assessment on a 10 cm horizontal visual analog scale of fatigue, axial pain, peripheral pain, enthesopathy and stiffness. Fifth and sixth questions are averaged. Addition to this score, other questions are averaged. Total score is between 0 and 10. Higher score represent worse outcome.

    Time frame: 1 minute

  7. International Physical Activity Questionnaire- Short Form

    This questionnaire obtains information about how much time is spent while walking and in moderate and vigorous activities and sitting duration in the last 7 days. The questionnaire records the activity of four intensity levels: 1) vigorous-intensity activity, 2) moderate-intensity activity, 3) walking, and 4) sitting. Durations are multiplied by known METs per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. A sitting question is not included in physical activity score. The questionnaire is scored as: those who score high on the IPAQ engage in vigorous intensity activity of at least 1500 MET minutes a week, those who score modarete on the IPAQ of at least 600 MET minutes a week, those who score a low level of physical activity on the IPAQ means that not meeting any of the criteria for either moderate or high levels of physical activity

    Time frame: 1 minute

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Study locations

1 of 1 sites recruiting
  • Gazi University
    Ankara, 06560, Turkey
    • Songul Baglan Yentur · Contact · songulbaglan23@hotmail.com · +90 506 272 6511
    • Devrim Can Sarac · Sub investigator
    • Gizem Tore · Sub investigator
    • Fulden Sari · Sub investigator
    • Hasan Satis · Sub investigator
    • Mehmet Akif Ozturk · Sub investigator
    • Deran Oskay · Sub investigator
    Recruiting
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References and documents

Publications

  • Altan L, Korkmaz N, Dizdar M, Yurtkuran M. Effect of Pilates training on people with ankylosing spondylitis. Rheumatol Int. 2012 Jul;32(7):2093-9. doi: 10.1007/s00296-011-1932-9. Epub 2011 Apr 17. PubMed 21499876 ↗
  • Rosu MO, Topa I, Chirieac R, Ancuta C. Effects of Pilates, McKenzie and Heckscher training on disease activity, spinal motility and pulmonary function in patients with ankylosing spondylitis: a randomized controlled trial. Rheumatol Int. 2014 Mar;34(3):367-72. doi: 10.1007/s00296-013-2869-y. Epub 2013 Sep 26. PubMed 24071935 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03904953
Lead sponsor
Gazi University
Responsible party
Songul Baglan Yentur (Research Assistant, Gazi University) — Principal investigator
First posted
Apr 5, 2019
Start date
Apr 2, 2019
Primary completion
Jun 2, 2019 (estimated)
Completion
Oct 2, 2019 (estimated)
Last update
Apr 9, 2019

Study contacts

Songul Baglan Yentur
Contact
songulbaglan23@hotmail.com
+90 312 216 26 12
Deran Oskay
study director · Gazi University Faculty of Health Sciences

Oversight

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

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