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临床试验/NCT02702791
NCT02702791已完成不适用

Enhancing Physical Activity to Achieve Sustainable Benefits in Extrapulmonary Consequences of COPD

KU Leuven2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2015年10月最近更新:
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
73
试验地点
2
主要终点
Changes in physical activity (number of steps)

研究概览

简要总结

This randomized control trial will investigate whether the implementation of a telecoaching program, initiated during pulmonary rehabilitation, is able to increase and maintain physical activity and general benefits until six months after rehabilitation discharge.

After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be randomized to either an intervention group which receives an additional telecoaching program on top of the pulmonary rehabilitation, or to the usual care group, which only receives rehabilitation program. Apart from the added telecoaching program to the intervention group, the rehabilitation program will be identical and last for another three months (2 times a week). After discharge, both groups will be followed up for six months.

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
None

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

入选标准

  • Patients with a primary diagnosis of COPD according to internationally accepted guidelines
  • Patients that completed three months of the outpatient pulmonary rehabilitation program of Gasthuisberg University Hospital (Leuven, Belgium)
  • Current or previous smoking exposure of at least 10 pack years
  • Ability to manage electronic devices (smartphone, step counter)

排除标准

  • Other predominant respiratory diseases than COPD (asthma, pulmonary hypertension)
  • Orthopedic, neurological and muscular co morbidities that could interfere with normal biomechanical movement patterns and the ability to increase physical activity levels
  • Patients on the waiting list for lung transplantation

研究组 & 干预措施

Intervention

Experimental

Telecoaching - feasible goal setting and feedback to enhance patient's motivation and commitment - in addition to pulmonary rehabilitation.

干预措施: Telecoaching (Behavioral)

Intervention

Experimental

Telecoaching - feasible goal setting and feedback to enhance patient's motivation and commitment - in addition to pulmonary rehabilitation.

干预措施: pulmonary rehabilitation (Other)

Usual care

Other

includes only general advices regarding physical activity.

干预措施: pulmonary rehabilitation (Other)

结局指标

主要结局

Changes in physical activity (number of steps)

时间窗: At three and six months of pulmonary rehabilitation and three and six months of follow up

次要结局

  • Changes in pulmonary rehabilitation outcomes (Quality of life)(At three and six months of pulmonary rehabilitation and six months of follow up)
  • Changes in pulmonary rehabilitation outcomes (Quadriceps force)(At three and six months of pulmonary rehabilitation and three and six months of follow up)
  • Changes in physical activity (time spent in moderate activity)(At three and six months of pulmonary rehabilitation and three and six months of follow up)
  • Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)(At three and six months of pulmonary rehabilitation and three and six months of follow up)
  • Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)(At three and six months of pulmonary rehabilitation and six months of follow up)
  • Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)(At three and six months of pulmonary rehabilitation and six months of follow up)

研究者

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

Thierry Troosters

Prof

KU Leuven

研究点 (2)

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