NCT03400839Unknown不适用
Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Changes of daily steps over time
研究概览
简要总结
This prospective cohort study will investigate whether progression of the interstitial lung diseases is related to specific clinical endpoints and their changes over time. Longitudinal data of patients will be compared to an age-matched control group during a follow-up of at least two years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with interstitial lung disease:
- •Age between 40 and 75 years old upon inclusion;
- •Diagnosis of interstitial lung disease;
- •Clinical stability for at least 4 weeks prior to inclusion;
- •Absence of any comorbidity that interferes with the performance of tests;
- •Age-matched control group:
- •Age between 40 and 75 years old upon inclusion;
- •Absence of any comorbidity that interferes with the performance of tests;
- •Exclusion Criteria (both groups):
- •Participants that present severe or unstable cardiac disease identified during the cardiopulmonary exercise testing;
- •Participants with cognitive deficit that interfere with any of the tests;
排除标准
- 未提供
结局指标
主要结局
Changes of daily steps over time
时间窗: from date of inclusion until the date of study completion or until the documented date of death from any cause, whichever came first, up to 48 months
Changes in daily steps (measured using an activity monitor) at every 6-month interval until study completion or end of participation in the study.
次要结局
未报告次要终点
研究者
研究点 (1)
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