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临床试验/NCT02223962
NCT02223962已完成不适用

The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.

KU Leuven1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
30
试验地点
1
主要终点
Improvement in physical activity

研究概览

简要总结

Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.

详细描述

After signing the informed consent, the patients will be randomized into a control group, receiving usual care, or the intervention group receiving real-time feedback and physical activity counseling.

Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts based on the step count from the Fitbit Ultra. In agreement with the patient and based on the step counts a patients provided, a new goal for the next week was set. The goal was to strive for the highest possible level of physical activity during one month.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Signed Informed Consent
  • •Chronic Obstructive Lung Disease (Tiff<70%)
  • •Hospitalized because of exacerbation
  • •Capable of working with electronic devices

排除标准

  • •Orthopedic/Neurologic problems making it difficult to be active
  • •Participation in a rehabilitation program

研究组 & 干预措施

Physical activity

Experimental

The fitbit Ultra was used to provide real-time feedback on physical activity. An experienced physiotherapist contacted the subjects 3 times a week to receive information about the amount of steps from the previous days. In agreement with the patient, a new goal for the coming weeks was set and patients were motivated to achieve their individual goal.

干预措施: Physical activity (Behavioral)

Usual Care

Placebo Comparator

During the hospital stay, the patients in the control group will be informed about the beneficial effects of being physically inactive.They will not receive feedback about their activities performed and will not be stimulated to become more active.

干预措施: Physical activity (Behavioral)

结局指标

主要结局

Improvement in physical activity

时间窗: 1 month

The Dynaport MoveMonitor, a valid device in patients with COPD, was used to accurately measure the level of physical activity. The device was provided 3 times to the patients (baseline, after 2 weeks, after 1 month). The amount of steps, measured by this device, was used as the outcome measure.

次要结局

  • Improvement in functional exercise capacity(1 month)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Decramer

Prof. Dr.

KU Leuven

研究点 (1)

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