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临床试验/NCT03084874
NCT03084874Unknown不适用

Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Exacerbation That Require Hospitalization

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017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
入组人数
66
试验地点
1
主要终点
Change in steps per day

研究概览

简要总结

Patients with COPD are more inactive and more sedentary than subjects of the same age and patients with other chronic diseases. This inactivity and sedentary behavior is accentuated after hospitalizations due to a COPD exacerbation, and it increases the risk for future hospitalizations and mortality. Therefore, there is a need for intervention to promote physical activity and to reduce sedentary behavior after these events. The present study aims to evaluate the efficacy of a coaching program to promote physical activity and reduce sedentary behavior in patients with COPD who have suffered a hospitalization due to a COPD exacerbation. Sixty-six COPD patients admitted to the hospital will be recruited during 18 months. Physical activity, sedentary behaviors, as well as other clinical and functional parameters will be evaluated after hospital discharge. Patients will be then randomized to an intervention and control group (1:1). The intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process). The control group will receive the usual care during follow-up. Physical activity, sedentary behaviors, as well as the clinical and functional variables will be evaluated again at 12 weeks in both patients' groups.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Previous diagnosis of COPD according to spirometric criteria (post-bronchodilator FEV1 / FVC less than 70%)
  • •Smoking exposure> 10 paq/year.
  • •Age greater than 40 years.
  • •Hospitalization due to a COPD exacerbation
  • •Written informed consent.

排除标准

  • •Patients needing the care of an Intensive Care Unit.
  • •Patients who have been hospitalized more than once for a COPD exacerbation in the previous 12 months (at least 3 months from last discharge).
  • •Patients with continuous oxygen therapy who do not have a portable source before admission.
  • •Patients with severe hypoxemia at rest (SpO2 <85% at rest) at discharge
  • •Mental incapacity, severe comorbidity, general fragility or advanced age that could substantially difficult patient's participation in the study.
  • •Patients who need mechanical aids for walking.
  • •Patients participating in a pulmonary rehabilitation program.
  • •Difficulty understanding Spanish / Catalan.

研究组 & 干预措施

Intervention group

Experimental

Patients in the intervention group will receive an individualized coaching program to increase physical activity and reduce sedentary behavior during 12 weeks

干预措施: Physical activity and sedentary behavior coaching program (Behavioral)

Control group

No Intervention

Patients in the control group will receive the standard care for patients with COPD during 12 weeks.

结局指标

主要结局

Change in steps per day

时间窗: Baseline and 12 weeks

Steps per day will be objectively measured with an accelerometer

Change in the number of active periods per day

时间窗: Baseline and 12 weeks

Number of periods spent standing, walking or shuffling objectively measured with an accelerometer

Change in time spend in light and moderate physical activity

时间窗: Baseline and 12 weeks

Time spend in light and moderate physical activity (1.5-3 and 3-6 METS) objectively measured with an accelerometer

Change in time spend in sedentary behavior

时间窗: Baseline and 12 weeks

Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer

Breaks in sedentary behaviour

时间窗: Baseline and 12 weeks

Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer

次要结局

  • Change in exercise capacity(Baseline and 12 weeks)
  • Change in muscle force(Baseline and 12 weeks)
  • Change in patient's quality of life(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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