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临床试验/NCT05227443
NCT05227443已完成不适用

Effects of Different Exercise Training Programs on the Functional Performance in Fibrosing Interstitial Lung Diseases

Alexandria University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Maximum oxygen consumption

研究概览

简要总结

The current study recruited patients with fibrosing interstitial lung diseases (f-ILD) whatever was the underlying pathology. The investigators aimed to compare the effects of aerobic exercises for lower limbs (LL) versus upper limbs, lower limbs, and breathing exercises (ULB) on the peak exercise measurements that was measured using cardiopulmonary exercise testing (CPET), dyspnea and health related quality of life assessment in this group of patients.

详细描述

The investigators conducted a case-control study with a follow up after 6 weeks (short term). All the participants on recruited were evaluated clinically. A high resolution computed tomography (HRCT) scan of the chest was performed to confirm the diagnosis of f-ILD as well as a spirometry. All the patients were subjected to cardiopulmonary exercise testing (CPET), 6-minute walk test (6-MWT), evaluation of dyspnea using mMRC dyspnea scale, and evaluation of health related quality of life using St. George's Respiratory Questionnaire (SGRQ). The control group were followed up by telephone calls. The intervention groups (LL and ULB) were subjected randomly to aerobic exercise training for 6 weeks. After termination of all the session, the patients were re-evaluated clinically and objectively using CPET, 6-MWT, mMRC and SGRQ. Also, we evaluated the outcome of the patients (control and intervention groups) as those who died or reported exacerbation of the underlying disease were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Adult patients aged ≥ 18 years.
  • Fibrosis interstitial lung diseases (f-ILDs) diagnosed based on HRCT radiological features.
  • Restrictive or mixed pattern in forced spirometry test

排除标准

  • Motor disabilities
  • Cardiovascular diseases (as acute heart failure, unstable angina or recent myocardial infarction)
  • Cognitive impairments
  • History of cerebrovascular accident
  • Active cancer
  • Life expectancy less than 3 months.

结局指标

主要结局

Maximum oxygen consumption

时间窗: 6 weeks

Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.

Quality of life evaluation

时间窗: 6 weeks

St. George's Respiratory Questionnaire (SGRQ) was used to assess the health related quality of life. SGRS constitutes 50 items and the score ranging from 0 to 100, with higher scores indicating more limitations.

次要结局

  • Dyspnea(6 weeks)
  • Resting oxygen saturation(6 weeks)

研究者

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

Hanaa Shafiek

Assistant professor

Alexandria University

研究点 (2)

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