Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Hospitalization
Primary Purpose
Chronic Obstructive Pulmonary Disease, Physical Activity, Sedentary Lifestyle
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical activity and sedentary behavior coaching program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Physical Activity, Sedentary behaviour, Hospitalization
Eligibility Criteria
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.
Sites / Locations
- University Hospital Vall d'HebronRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Patients in the intervention group will receive an individualized coaching program to increase physical activity and reduce sedentary behavior during 12 weeks
Patients in the control group will receive the standard care for patients with COPD during 12 weeks.
Outcomes
Primary Outcome Measures
Change in steps per day
Steps per day will be objectively measured with an accelerometer
Change in the number of active periods per day
Number of periods spent standing, walking or shuffling objectively measured with an accelerometer
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
Change in time spend in sedentary behavior
Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer
Breaks in sedentary behaviour
Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer
Secondary Outcome Measures
Change in exercise capacity
Distance walked in the 6-minute walk test
Change in muscle force
Quadriceps muscle force tested with a hand-held dynamometer
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)
Full Information
NCT ID
NCT03084874
First Posted
March 14, 2017
Last Updated
March 14, 2017
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Spanish Society of Pneumology and Thoracic Surgery
1. Study Identification
Unique Protocol Identification Number
NCT03084874
Brief Title
Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Hospitalization
Official Title
Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Exacerbation That Require Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2017 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Spanish Society of Pneumology and Thoracic Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Physical Activity, Sedentary Lifestyle
Keywords
COPD, Physical Activity, Sedentary behaviour, Hospitalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients in the intervention group will receive an individualized coaching program to increase physical activity and reduce sedentary behavior during 12 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group will receive the standard care for patients with COPD during 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity and sedentary behavior coaching program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in steps per day
Description
Steps per day will be objectively measured with an accelerometer
Time Frame
Baseline and 12 weeks
Title
Change in the number of active periods per day
Description
Number of periods spent standing, walking or shuffling objectively measured with an accelerometer
Time Frame
Baseline and 12 weeks
Title
Change in time spend in light and moderate physical activity
Description
Time spend in light and moderate physical activity (1.5-3 and 3-6 METS) objectively measured with an accelerometer
Time Frame
Baseline and 12 weeks
Title
Change in time spend in sedentary behavior
Description
Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer
Time Frame
Baseline and 12 weeks
Title
Breaks in sedentary behaviour
Description
Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in exercise capacity
Description
Distance walked in the 6-minute walk test
Time Frame
Baseline and 12 weeks
Title
Change in muscle force
Description
Quadriceps muscle force tested with a hand-held dynamometer
Time Frame
Baseline and 12 weeks
Title
Change in patient's quality of life
Description
patient's quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) anbd the COPD assesment test (CAT)
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in patients's anxiety and depression
Description
Patient's anxiety and depression measured using the Hospital Anxiety and Depression scale (HADS)
Time Frame
Baseline and 12 weeks
Title
Change in dyspnoea during daily activities
Description
Dyspnoea during daily activities measures using the London Chest Activity of Daily Living scale (LCADL)
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria A Ramon, PT, PhD
Phone
0034932746107
Email
maramon@vhebron.net
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Rodriguez, MD, PhD
Phone
0034932746083
Email
estherod@vhebron.net
Facility Information:
Facility Name
University Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria A Ramon, PT, PhD
Email
maramon@vhebron.net
First Name & Middle Initial & Last Name & Degree
Esther Rodríguez, MD, PhD
Email
estherod@vhebron.net
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared
Learn more about this trial
Efficacy of a Coaching Program to Promote Physical Activity and Reduce Sedentary Behavior After a COPD Hospitalization
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