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

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ClinicalTrials.gov Identifier: NCT03904953
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Songul Baglan Yentur, Gazi University

Brief 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.


Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Other: Pilates Training Other: Conventional exercise programme Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pilates Training on Respiratory Muscle Strenght in Patients With Ankylosing Spondylitis
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : June 2, 2019
Estimated Study Completion Date : October 2, 2019


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

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
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.




Primary Outcome Measures :
  1. Respiratory muscle strength [ Time Frame: 5 minutes ]
    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


Secondary Outcome Measures :
  1. Bath Ankylosing Spondylitis Metrology Index [ Time Frame: 5 minutes ]
    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.

  2. Ankylosing Spondylitis Quality of Life Questionnaire [ Time Frame: 1 minute ]
    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

  3. Thorax pain [ Time Frame: 1 minute ]
    Visual Analog Scale (VAS) will be used to determine the intensity of thorax pain; 0 means 'no pain' while 10 means 'unbearable pain'.

  4. Chest expansion [ Time Frame: 2 minutes ]
    Chest expansion will be measured with a tape placed circumferentially around the chest wall (axillar, subcostal, epigastric) in cm.

  5. Aerobic capacity [ Time Frame: 10 minutes ]
    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

  6. Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: 1 minute ]
    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.

  7. International Physical Activity Questionnaire- Short Form [ Time Frame: 1 minute ]
    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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904953


Contacts
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Contact: Songul Baglan Yentur +90 312 216 26 12 songulbaglan23@hotmail.com

Locations
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Turkey
Gazi University Recruiting
Ankara, Turkey, 06560
Contact: Songul Baglan Yentur    +90 506 272 6511    songulbaglan23@hotmail.com   
Sub-Investigator: Devrim Can Sarac         
Sub-Investigator: Gizem Tore         
Sub-Investigator: Fulden Sari         
Sub-Investigator: Hasan Satis         
Sub-Investigator: Mehmet Akif Ozturk         
Sub-Investigator: Deran Oskay         
Sponsors and Collaborators
Gazi University
Investigators
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Study Director: Deran Oskay Gazi University Faculty of Health Sciences

Publications:
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Responsible Party: Songul Baglan Yentur, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03904953     History of Changes
Other Study ID Numbers: 43
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Songul Baglan Yentur, Gazi University:
Ankylosing Spondylitis
Pilates
Respiratory muscle strenght
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis