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临床试验/NCT03904953
NCT03904953Unknown不适用

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

Gazi University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Respiratory muscle strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Study group

Experimental

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

干预措施: Pilates Training (Other)

Control group

Active Comparator

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.

干预措施: Conventional exercise programme (Other)

结局指标

主要结局

Respiratory muscle strength

时间窗: 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

次要结局

  • Ankylosing Spondylitis Quality of Life Questionnaire(1 minute)
  • Bath Ankylosing Spondylitis Metrology Index(5 minutes)
  • Thorax pain(1 minute)
  • Aerobic capacity(10 minutes)
  • Bath Ankylosing Spondylitis Disease Activity Index(1 minute)
  • Chest expansion(2 minutes)
  • International Physical Activity Questionnaire- Short Form(1 minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Songul Baglan Yentur

Research Assistant

Gazi University

研究点 (2)

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