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

NCT ID: NCT03084874

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease; Physical Activity; Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Physical activity and sedentary behavior coaching program

Intervention Type: BEHAVIORAL

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).

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity and sedentary behavior coaching program

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Pneumology and Thoracic Surgery

OTHER

Sponsor Role: collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maria A Ramon, PT, PhD

Role: CONTACT

maramon@vhebron.net

0034932746107

Esther Rodriguez, MD, PhD

Role: CONTACT

estherod@vhebron.net

0034932746083

Facility Contacts

Maria A Ramon, PT, PhD

Role: primary

maramon@vhebron.net

Esther Rodríguez, MD, PhD

Role: backup

estherod@vhebron.net

Other Identifiers

PR(AG)390/2015

Identifier Type: -

Identifier Source: org_study_id