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Clinical Trials/NCT03084874
NCT03084874
Unknown
Not Applicable

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 site in 1 country66 target enrollmentMarch 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
66
Locations
1
Primary Endpoint
Change in steps per day
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2017
End Date
December 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Change in steps per day

Time Frame: Baseline and 12 weeks

Steps per day will be objectively measured with an accelerometer

Change in the number of active periods per day

Time Frame: 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

Time Frame: 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

Time Frame: Baseline and 12 weeks

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

Breaks in sedentary behaviour

Time Frame: Baseline and 12 weeks

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

Secondary Outcomes

  • 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)

Study Sites (1)

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