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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03084874
• Other study ID #: PR(AG)390/2015
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 14, 2017
• Start date: March 2017
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Maria A Ramon, PT, PhD
• Phone: 0034932746107
• Email: maramon[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Physical Activity
• Pulmonary Disease, Chronic Obstructive
• Sedentary Lifestyle

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Spain	University Hospital Vall d'Hebron	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Spanish Society of Pneumology and Thoracic Surgery

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in patients's anxiety and depression	Patient's anxiety and depression measured using the Hospital Anxiety and Depression scale (HADS)	Baseline and 12 weeks
Other	Change in dyspnoea during daily activities	Dyspnoea during daily activities measures using the London Chest Activity of Daily Living scale (LCADL)	Baseline and 12 weeks
Primary	Change in steps per day	Steps per day will be objectively measured with an accelerometer	Baseline and 12 weeks
Primary	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
Primary	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
Primary	Change in time spend in sedentary behavior	Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer	Baseline and 12 weeks
Primary	Breaks in sedentary behaviour	Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer	Baseline and 12 weeks
Secondary	Change in exercise capacity	Distance walked in the 6-minute walk test	Baseline and 12 weeks
Secondary	Change in muscle force	Quadriceps muscle force tested with a hand-held dynamometer	Baseline and 12 weeks
Secondary	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