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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease, Physical Activity, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Physical activity and sedentary behavior coaching program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients in the intervention group will receive an individualized coaching program to increase physical activity and reduce sedentary behavior during 12 weeks | Behavioral: Physical activity and sedentary behavior coaching program<br>* 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).<br>|
| No Intervention: Control group<br>Patients in the control group will receive the standard care for patients with COPD during 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in steps per day | Steps per day will be objectively measured with an accelerometer | Baseline and 12 weeks | 
| Change in the number of active periods per day | Number of periods spent standing, walking or shuffling objectively measured with an accelerometer | Baseline and 12 weeks | 
| Change in time spend in light and moderate physical activity | Time spend in light and moderate physical activity (1.5-3 and 3-6 METS) objectively measured with an accelerometer | Baseline and 12 weeks | 
| Change in time spend in sedentary behavior | Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer | Baseline and 12 weeks | 
| Breaks in sedentary behaviour | Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise capacity | Distance walked in the 6-minute walk test | Baseline and 12 weeks | 
| Change in muscle force | Quadriceps muscle force tested with a hand-held dynamometer | Baseline and 12 weeks | 
| Change in patient's quality of life | patient's quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) anbd the COPD assesment test (CAT) | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Physical Activity, Sedentary behaviour, Hospitalization