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

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Training
Conventional exercise programme
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, Pilates, Respiratory muscle strenght

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2019
Last Updated
April 5, 2019
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT03904953
Brief Title
Effects of Pilates Training on Respiratory Muscle Strenght in Patients With Ankylosing Spondylitis
Official Title
Effects of Pilates Training on Respiratory Muscle Strenght in Patients With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
June 2, 2019 (Anticipated)
Study Completion Date
October 2, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis, Pilates, Respiratory muscle strenght

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates Training
Intervention Description
Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Conventional exercise programme
Intervention Description
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 Measure Information:
Title
Respiratory muscle strength
Description
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 Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Metrology Index
Description
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
Title
Ankylosing Spondylitis Quality of Life Questionnaire
Description
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
Title
Thorax pain
Description
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
Title
Chest expansion
Description
Chest expansion will be measured with a tape placed circumferentially around the chest wall (axillar, subcostal, epigastric) in cm.
Time Frame
2 minutes
Title
Aerobic capacity
Description
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
Title
Bath Ankylosing Spondylitis Disease Activity Index
Description
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
Title
International Physical Activity Questionnaire- Short Form
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songul Baglan Yentur
Phone
+90 312 216 26 12
Email
songulbaglan23@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deran Oskay
Organizational Affiliation
Gazi University Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songul Baglan Yentur
Phone
+90 506 272 6511
Email
songulbaglan23@hotmail.com
First Name & Middle Initial & Last Name & Degree
Devrim Can Sarac
First Name & Middle Initial & Last Name & Degree
Gizem Tore
First Name & Middle Initial & Last Name & Degree
Fulden Sari
First Name & Middle Initial & Last Name & Degree
Hasan Satis
First Name & Middle Initial & Last Name & Degree
Mehmet Akif Ozturk
First Name & Middle Initial & Last Name & Degree
Deran Oskay

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21499876
Citation
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.
Results Reference
background
PubMed Identifier
24071935
Citation
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.
Results Reference
background

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

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