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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KU Leuven
- Enrollment
- 370
- Locations
- 6
- Primary Endpoint
- Daily number of steps
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Usual care
Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status
Coaching program
In addition to usual care, patients will receive the coaching program
Intervention: Coaching program (Other)
Outcomes
Primary Outcomes
Daily number of steps
Time Frame: 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 Outcomes
- Time spent in at least moderate physical activity(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(changes form baseline to 3 months)
- Proportion of patients showing an increase of physical activity by >20%(changes from baseline to 3 months)
Investigators
Thierry Troosters
Prof. Dr.
KU Leuven