跳至主要内容
临床试验/NCT05240326
NCT05240326Unknown不适用

Investigation of the Effect of Clinical Pilates Training on Functional Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis

Gazi University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Functional exercise capacity

研究概览

简要总结

Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with significant functional impairment and increased risk for cardiovascular and pulmonary disease. Along with pharmacological therapy, exercise seems to be a very promising intervention to improve disease-related outcomes, including functional capacity and systemic manifestations. Despite the fact that aerobic and strengthening exercises have been shown to be useful in patients with RA, there have been limited research on the effects of pilates training. Therefore, we aimed to investigate the effect of clinical pilates training on exercise capacity, respiratory and peripheral muscle strength, respiratory muscle endurance, respiratory function, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety in patients with RA.

详细描述

According to sample size calculation 30 patients with RA will be included. Patients will be evaluated before and after treatment. Patients will be randomized into exercise and control training groups. In the exercise training group the patients will be given pilates exercise; in the control training group, the patients will be given relaxation exercise. Pilates exercises will be applied by the physiotherapist 3 days a week for 8 weeks. The patients in the control training group will be given relaxation exercises as a home exercise program 3 days a week for 8 weeks. Exercise capacity, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety will be evaluated.

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 (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years old
  • Being diagnosed according to the American College of Rheumatology (ACR)/EULAR 2010 rheumatoid arthritis diagnostic criteria
  • under standard medications

排除标准

  • orthopedic or neurological disease with a potential to affect functional capacity
  • have problems that can prevent evaluation
  • have a neurological problem that may cause hearing or vision impairment
  • changes in medical treatment in the last 3 months
  • have high disease activity score (DAS-28>3.2)

结局指标

主要结局

Functional exercise capacity

时间窗: First day

It will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.

Pulmonary functions contains dynamic lung volumes

时间窗: First day

Spirometry will be used to perform pulmonary function testing in accordance with the American Thoracic Society and European Respiratory Society guidelines.

Respiratory muscle strength

时间窗: First day

Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.

Respiratory muscle endurance

时间窗: First day

It will be assessed using an incremental threshold loading test, in which patients began with a load of 30% of maximum inspiratory pressure and increased by 10% every 2 minutes.

次要结局

  • Pain level(First day)
  • Core stability(Second day)
  • Balance(Second day)
  • Disease Specific Quality of Life(Second day)
  • Functional status(First day)
  • Anxiety and depression(Second day)
  • Peripheral muscle strength(Second day)
  • Dyspnea(First day)
  • Fatigue(Second day)

研究者

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

Selin Bayram

Principal Investigator

Gazi University

研究点 (1)

Loading locations...

相似试验