Clinical trial NCT03084874: Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Hospitalization
Official title: Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Exacerbation That Require Hospitalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Physical Activity
Sedentary Lifestyle
Keywords: COPD
Physical Activity
Sedentary behaviour
Hospitalization
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Spanish Society of Pneumology and Thoracic Surgery
First posted: 2017-03-21
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in steps per day
timeFrame: Baseline and 12 weeks
measure: Change in the number of active periods per day
timeFrame: Baseline and 12 weeks
measure: Change in time spend in light and moderate physical activity
timeFrame: Baseline and 12 weeks
measure: Change in time spend in sedentary behavior
timeFrame: Baseline and 12 weeks
measure: Breaks in sedentary behaviour
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in exercise capacity
timeFrame: Baseline and 12 weeks
measure: Change in muscle force
timeFrame: Baseline and 12 weeks
measure: Change in patient's quality of life
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change in patients's anxiety and depression
timeFrame: Baseline and 12 weeks
measure: Change in dyspnoea during daily activities
timeFrame: Baseline and 12 weeks
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References: