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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Physical Activity; Sedentary Lifestyle
• Intervention / Treatment: Behavioral: Physical activity and sedentary behavior coaching program

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • University Hospital Vall d'Hebron
    • Contact: Maria A Ramon, PT, PhD; Email: maramon@vhebron.net
    • Contact: Esther Rodríguez, MD, PhD; Email: estherod@vhebron.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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).
No Intervention: Control group; Patients in the control group will receive the standard care for patients with COPD during 12 weeks.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Spanish Society of Pneumology and Thoracic Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Physical Activity; COPD; Hospitalization; Sedentary behaviour
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PR(AG)390/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No