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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; Physical Activity; Sedentary Lifestyle
• Interventions: Behavioral: Physical activity and sedentary behavior coaching program

• Registration Number: NCT03084874
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in the number of active periods per day	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	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	Baseline and 12 weeks	Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer
Breaks in sedentary behaviour	Baseline and 12 weeks	Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer
Change in steps per day	Baseline and 12 weeks	Steps per day will be objectively measured with an accelerometer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain