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临床试验/NCT06716008
NCT06716008尚未招募不适用

Effect of Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

Middle East University0 个研究点目标入组 60 人开始时间: 2024年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Ventilatory function

研究概览

简要总结

Evaluate the effect of manual diaphragmatic release on ventilatory functions in women with rheumatoid arthritis

详细描述

Sixty women with rheumatoid arthritis will be sourced from the rheumatology outpatient clinic at Tanta University hospitals in Egypt, with referrals from rheumatologists. Patients will be randomly assigned into two groups.

The study group will include 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks while the control group will include 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes will be assessed:

  1. Ventilatory functions (Forced vital capacity and total lung capacity).
  2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).
  3. Quality of life (Short form health survey).

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • All women will have rheumatoid arthritis for more than 2 years with low-to-moderate disease activity.
  • Normal to mildly restrictive lung pattern.
  • Their ages will be ranged from 40 to 60 years old.
  • Their body mass index will be less than 30 Kg/m2.

排除标准

  • Chronic chest diseases.
  • Recent parenteral steroid administration.
  • Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
  • Joint surgery (in the preceding 6 months).
  • Musculoskeletal/ neurological limitations to exercise.
  • Pregnancy.

结局指标

主要结局

Ventilatory function

时间窗: At baseline and 12 weeks

Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second will be measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.

次要结局

  • Functional capacity(At baseline and after 12 weeks)

研究者

发起方
Middle East University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Saher Lotfy El Gayar

Assistant Professor of Physical Therapy

Kasr El Aini Hospital

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