Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic obstructive pulmonary disease (COPD), physical activity, PROactive, telecoaching
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.
Interventions
OTHERCoaching program
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.
Sponsors
University of Edinburgh
Royal Brompton & Harefield NHS Foundation Trust
University Medical Center Groningen
University of Athens
University of Zurich
Barcelona Institute for Global Health
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 | 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 |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compliance with the telecoaching program | Information gathered after 3 months of intervention | Compliance of wearing the step counter and performing the tasks of the smartphone interface |
| Satisfaction with the telecoaching program | Information gathered after 3 months of intervention | Questionnaire and qualitative interview about the patients' experience |
| daily and clinic visit version of PROactive instrument | changes from baseline to 3 months | — |
Countries
Belgium, Greece, Netherlands, Switzerland, United Kingdom
Outcome results
None listed