Clinical trial NCT02158065: Impact of "Telecoaching Program" on Physical Activity in Patients With COPD
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease (COPD)
physical activity
PROactive
telecoaching
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: Royal Brompton & Harefield NHS Foundation Trust
name: University Medical Center Groningen
name: University of Athens
name: University of Zurich
name: Barcelona Institute for Global Health
First posted: 2014-06-06
Enrollment: 370
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily number of steps
timeFrame: changes from baseline to 3 months
Secondary outcomes:
measure: Time spent in at least moderate physical activity
timeFrame: changes from baseline to 3 months
measure: Proportion of patients showing an increase of physical activity by >20%
timeFrame: changes from baseline to 3 months
measure: 6-minute walking test
timeFrame: changes from baseline to 3 months
measure: isometric Quadriceps force
timeFrame: changes from baseline to 3 months
measure: COPD symptoms and health-related quality of life
timeFrame: changes form baseline to 3 months
Other outcomes:
measure: daily and clinic visit version of PROactive instrument
timeFrame: changes from baseline to 3 months
measure: Satisfaction with the telecoaching program
timeFrame: Information gathered after 3 months of intervention
measure: Compliance with the telecoaching program
timeFrame: Information gathered after 3 months of intervention
Locations:
city: Leuven
country: Belgium
facility: KULeuven
city: Athens
country: Greece
facility: Thorax Research Foundation
city: Groningen
country: Netherlands
facility: University Medical Center
city: Zurich
country: Switzerland
facility: University of Zurich
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Imperial College
Study officials:
affiliation: KU Leuven
name: Thierry Troosters, PT, PHD
role: STUDY_CHAIR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Mike Polkey, MD, PHD
role: STUDY_CHAIR
affiliation: Barcelona Institute for Global Health
name: Judith Garcia-Aymerich, MD, PHD
role: STUDY_CHAIR
References:
citation: Loeckx M, Rabinovich RA, Demeyer H, Louvaris Z, Tanner R, Rubio N, Frei A, De Jong C, Gimeno-Santos E, Rodrigues FM, Buttery SC, Hopkinson NS, Busching G, Strassmann A, Serra I, Vogiatzis I, Garcia-Aymerich J, Polkey MI, Troosters T. Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. JMIR Mhealth Uhealth. 2018 Dec 21;6(12):e200. doi: 10.2196/mhealth.9774.
citation: Demeyer H, Louvaris Z, Frei A, Rabinovich RA, de Jong C, Gimeno-Santos E, Loeckx M, Buttery SC, Rubio N, Van der Molen T, Hopkinson NS, Vogiatzis I, Puhan MA, Garcia-Aymerich J, Polkey MI, Troosters T; Mr Papp PROactive study group and the PROactive consortium. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017 May;72(5):415-423. doi: 10.1136/thoraxjnl-2016-209026. Epub 2017 Jan 30.