Impact of Telecoaching Program on Physical Activity in Patients With COPD

Study Overview
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Brief Summary
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The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.

Detailed Description
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In this 3 month, randomized (1:1 ratio), parallel-group, multicenter trial, patients in both groups (control and coaching) will receive information and guidance on the benefits associated with increased physical activity in COPD patients and their health status. Patients in both groups will use two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire. In addition to above, the patients in the coaching group will receive daily coaching by a semiautomated system and coaching by the investigator during study visits.

Official Title
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A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Coaching program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained before any assessment is performed Male and female patients ≥ 40 years of age Diagnosis of COPD (GOLD criteria: post bronchodilator FEV1/FVC< 70%) Current or ex-smokers with a smoking history equivalent to at least 10 pack years Patient should have at least 4 days of physical activity data recorded via PROactive monitors during 7 days prior to the baseline measurement Exclusion Criteria: Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased, then they should not be enrolled Respiratory diseases other than COPD (e.g. asthma) Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the smartphone and PDA, as judged by the investigator Participating in or scheduled to start an outpatient rehabilitation program during the study. If the patient wishes to participate in pulmonary rehabilitation for any reason the patient can be enrolled in the study only at the end of rehabilitation

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status | |
| Experimental: Coaching program<br>In addition to usual care, patients will receive the coaching program | Other: Coaching program<br>* The coaching program consists of a (1) Step counter used as a coaching activity monitor to collect number of steps walked by the patients and (2) the Linkcare System, a mobile phone or tablet PC placed in the patient's home to collect data from the step counter. The system will set a daily activity goal for the patient based on achieved activity levels which will be measured by the step counter. Patients will also receive feedback, motivational and educational messages and direct calls from the coaching team at each institution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily number of steps | The daily number of steps will be measured by the PROactive monitors (ActiGraph® and DynaPort®) at baseline (during the week prior to baseline visit) and at the end of the 3-month epoch (during the week prior to end visit). | changes from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in at least moderate physical activity | Time in at least moderate physical activity will be measured by the PROactive monitors (ActiGraph® and DynaPort®) at baseline (during the week prior to baseline visit) and at the end of the 3-month epoch (during the week prior to end visit). | changes from baseline to 3 months | 
| Proportion of patients showing an increase of physical activity by >20% | Physical activity will be measured by the PROactive monitors (ActiGraph® and DynaPort®) at baseline (during the week prior to baseline visit) and at the end of the 3-month epoch (during the week prior to end visit). | changes from baseline to 3 months | 
| 6-minute walking test |  | changes from baseline to 3 months | 
| isometric Quadriceps force |  | changes from baseline to 3 months | 
| COPD symptoms and health-related quality of life | COPD symptoms and health-related quality of life will be measured by the CAT, CCQ, HADS and mMRC questionnaires | changes form baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease (COPD), physical activity, PROactive, telecoaching