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临床试验/NCT07031362
NCT07031362已完成不适用

Effects of Pulmonary Rehabilitation on Distance-Saturation Product and Clinical Outcomes in IPF Patients With and Without Exercise-Induced Desaturation

Izmir Katip Celebi University0 个研究点目标入组 50 人开始时间: 2013年1月1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
主要终点
Exercise capacity

研究概览

简要总结

The aim of this study is to evaluate the effects of a pulmonary rehabilitation (PR) program on health outcomes and the distance-saturation product in patients with IPF, by comparing two distinct groups: those who experience desaturation and those who do not during the six-minute walk test (6MWT).

详细描述

Exercise-induced dyspnea and desaturation are distinguishing features of patients with idiopathic pulmonary fibrosis (IPF); these symptoms are associated with disease severity and poorer prognosis. The distance-saturation product, which combines the distance walked and oxygen saturation by multiplying the two measures, has been identified as a predictor of mortality.

Patients with IPF who completed the pulmonary rehabilitation (PR) program were included in the study. Pre- and post-program assessments included spirometric measurements, arterial blood gas values, perception of dyspnea using the Modified Medical Research Council (mMRC) dyspnea scale, exercise capacity via the six-minute walk test (6MWT), health-related quality of life using the St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36), and psychological symptoms assessed with the Hospital Anxiety and Depression Scale (HADS). Additionally, the distance-saturation product was calculated by multiplying the distance walked by the oxygen saturation at the end of the 6MWT. Patients whose oxygen saturation dropped to 88% or below during the pre-rehabilitation 6MWT were classified as the desaturation group, while those with oxygen saturation of 89% or above were classified as the non-desaturation group. The obtained data were compared between these two groups.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Idiopathic Pulmonary Fibrosis Patients who initiated antifibrotic therapy Patients who completed the pulmonary rehabilitation program.

排除标准

  • Kardiovascular comorbid conditions

结局指标

主要结局

Exercise capacity

时间窗: up to 8 weeks

Six minute walk test

次要结局

  • Dyspnea Sensation(Before and after the pulmonary rehabilitation programme (up to 8 weeks))
  • Respiratory Functions(Before and after the pulmonary rehabilitation programme (up to 8 weeks))
  • Disease Related Quality of Life Measurement(Before and after the pulmonary rehabilitation programme (up to 8 weeks))
  • Health-Related Quality of Life Measurement(Before and after the pulmonary rehabilitation programme (up to 8 weeks))
  • Anxiety and Depression(Before and after the pulmonary rehabilitation programme (up to 8 weeks))

研究者

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

Ilknur Naz

Prof. Dr.

Izmir Katip Celebi University

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