Impact of "Telecoaching Program" on Physical Activity in Patients With COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Other: Coaching program
- Registration Number
- NCT02158065
- Lead Sponsor
- KU Leuven
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coaching program Coaching program In addition to usual care, patients will receive the coaching program
- Primary Outcome Measures
Name Time Method Daily number of steps changes from baseline to 3 months 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).
- Secondary Outcome Measures
Name Time Method 6-minute walking test changes from baseline to 3 months Time spent in at least moderate physical activity changes from baseline to 3 months 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).
isometric Quadriceps force changes from baseline to 3 months COPD symptoms and health-related quality of life changes form baseline to 3 months COPD symptoms and health-related quality of life will be measured by the CAT, CCQ, HADS and mMRC questionnaires
Proportion of patients showing an increase of physical activity by >20% changes from baseline to 3 months 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).
Trial Locations
- Locations (6)
KULeuven
🇧🇪Leuven, Belgium
Thorax Research Foundation
🇬🇷Athens, Greece
University of Zurich
🇨🇭Zurich, Switzerland
University Medical Center
🇳🇱Groningen, Netherlands
Royal Brompton Hospital, Imperial College
🇬🇧London, United Kingdom
University of Edinburgh
🇬🇧Edinburgh, United Kingdom