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临床试验/NCT06490796
NCT06490796已完成不适用

Which Respiratory Training is More Effective in Individuals with Ankylosing Spondylitis: 360-Degree Expandable Diaphragm Exercises or Standard Diaphragm Exercises? a Randomized Controlled Trial

Izmir University of Economics2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2024年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Spinal movements and spinal mobility

研究概览

简要总结

This study was designed to investigate and compare the effects of standard diaphragmatic breathing and physiotherapy exercises versus 360-degree expandable diaphragmatic breathing and physiotherapy exercises on respiratory functions, respiratory muscle strength, clinical course of the disease (such as thoracic mobility, flexibility), and functional status in individuals with Ankylosing Spondylitis (AS).

详细描述

One of the primary problems in Ankylosing Spondylitis (AS) is decreased thoracic expansion. For this reason, breathing exercises, especially thorax expansion, should be included. Moreover, according to Pascal's principle, the pressure applied to a closed fluid must be transmitted to every part of the fluid and to the walls of the space in which it is located, without decreasing (13). For this reason, it is thought that the disrupted breathing pattern cannot be adequately corrected by standard diaphragm exercises, in which the patient's hand is placed on the abdomen and the anterior abdominal wall is pushed forward/outward, and the diaphragm descent to the caudal level during inspiration with 360-degree expansion of the thoraco-abdominal cavity may not be sufficient (14). The aims of this study are as follows:

  1. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises and 360-degree expanded diaphragm exercises and physiotherapy exercises on respiratory function in individuals with AS.
  2. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on inspiratory and expiratory muscle strength in individuals with AS.
  3. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on spinal mobility and the clinical course of the disease in individuals with AS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20-60 years
  • Diagnosis according to the 1988 Modified New York criteria
  • Voluntary participation
  • BASDAI score of 3 or 4
  • No mental problems that could hinder cooperation and understanding

排除标准

  • Presence of a neurological disease
  • Other respiratory system diseases that could affect chest expansion (COPD, asthma, etc.)
  • Regular exercise within the last 3 months Additionally, individuals who miss four consecutive exercise sessions or require a change in treatment will be excluded from the study.

结局指标

主要结局

Spinal movements and spinal mobility

时间窗: From enrollment to the end of treatment at 6 weeks

The Bath Ankylosing Spondylitis Metrology Index (BASMI) will be used to measure clinical differences in spinal movements and spinal mobility. BASMI includes five measurements: cervical rotation, tragus-to-wall distance, lateral lumbar flexion, anterior lumbar flexion, and intermalleolar distance. A lower score on the BASMI indicates better spinal mobility (15).

次要结局

  • Disease activity(From enrollment to the end of treatment at 6 weeks)
  • Forced Expiratory Flow at 25-75% of FVC (FEF25-75%)(From enrollment to the end of treatment at 6 weeks)
  • Functional status(From enrollment to the end of treatment at 6 weeks)
  • Respiratory muscle strength(From enrollment to the end of treatment at 6 weeks)
  • Expiratory Forced Vital Capacity (FVC)(From enrollment to the end of treatment at 6 weeks)
  • Forced Expiratory Volume in one second (FEV1)(From enrollment to the end of treatment at 6 weeks)
  • FEV1/FVC ratio (FEV1%)(From enrollment to the end of treatment at 6 weeks)

研究者

发起方
Izmir University of Economics
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Yakit Yesilyurt

Assist Prof.

Izmir University of Economics

研究点 (2)

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