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临床试验/NCT02399254
NCT02399254已完成不适用

The Trajectory of Physical Activity Following Pulmonary Rehabilitation

Trinity Health Of New England4 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
4
主要终点
Minutes/Day at 48 Weeks

研究概览

简要总结

Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical activity in the home and community settings is less clear. It may take a longer time for this increase in physical activity to occur. It has been stated in an editorial that it takes 3 months to train the muscles but 6 months to train the brain. The Investigators will first evaluate the change in physical activity following pulmonary rehabilitation using state-of-the-science motion detectors, then Investigators will follow the trajectory of physical activity over the next several months.

详细描述

This study will follow physical activity following pulmonary rehabilitation longitudinally over 48 weeks. Investigators will use a state-of-the-art accelerometer, to analyze minutes walking per day as the primary outcome, rather than vector magnitude units (VMU) or estimated steps per day. Investigators will explore potential factors influencing this important outcome, including baseline activity levels, demographic variables, changes in exercise capacity, psychological variables, and self-efficacy scores. Finally, Investigators will evaluate the rate of change (trajectory) in physical activity over approximately six months after pulmonary rehabilitation. There are limited data suggesting it takes time for the translation of increased exercise capacity into increased physical activity to occur.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (≥ 40 years) with a primary clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • A post-bronchodilator forced expiratory volume in one second(FEV1)/forced vital capacity (FVC) < 0.70 from spirometry performed within the preceding 12 months (no specific FEV1 percent-predicted requirement, although we anticipate the FEV1 will average around 45% of predicted, based on previous studies of pulmonary rehabilitation)
  • The patient was referred to pulmonary rehabilitation
  • The patient is clinically-stable: no exacerbation in preceding 4 weeks
  • Modified Medical Research Council (mMRC) dyspnea rating of at least 2 out of 5.

排除标准

  • Disease severity or co-morbidity that would make the patient be at-risk for participation this study
  • A significant movement disorder, such as hemiplegia, etc.
  • Inability to read and comprehend the questionnaires, which will be in English
  • A history of poor wound healing or chronic skin conditions that might predispose to local problems from wearing the DynaPort. (The DynaPort can be worn outside a thin garment, such as a tee shirt, and is relatively thin, without protruding parts. However, since the device may be worn overnight, and there is a remote risk of pressure problems, this exclusion criterion was added).

结局指标

主要结局

Minutes/Day at 48 Weeks

时间窗: 48 weeks compared to baseline

Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 48 ± 3 week assessment and baseline.

Minutes/Day at 12 Weeks

时间窗: 12 weeks compared to baseline

Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 12 ± 3 week assessment and baseline.

次要结局

  • Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks(12 weeks compared to baseline)
  • Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks(48 weeks compared to baseline)

研究者

发起方
Trinity Health Of New England
申办方类型
Other
责任方
Sponsor

研究点 (4)

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