Pulmonary Disease, Chronic ObstructiveMrPAPPNCT02158065
Impact of "Telecoaching Program" on Physical Activity in Patients With COPD
A study testing Coaching program in people with Pulmonary Disease, Chronic Obstructive, run by KU Leuven at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Coaching program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 6 sitesin 5 countries
- Study dates
- May 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United Kingdom2 sites
University of Edinburgh
Edinburgh
Royal Brompton Hospital, Imperial College
London
About this study
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)
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Coaching program
- Keywords
- Chronic obstructive pulmonary disease (COPD), physical activity, PROactive, telecoaching
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status |
| Coaching program | Experimental | In addition to usual care, patients will receive the coaching program Receives: Other: Coaching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: changes from baseline to 3 months
Secondary outcomes (5)
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).
Measured: 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).
Measured: changes from baseline to 3 months
6-minute walking test
Measured: changes from baseline to 3 months
isometric Quadriceps force
Measured: 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
Measured: changes form baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Royal Brompton & Harefield NHS Foundation Trust, University Medical Center Groningen, University of Athens, University of Zurich, Barcelona Institute for Global Health
- Responsible party
- Principal investigator, Thierry Troosters, KU Leuven
- Investigators
- Thierry Troosters, PT, PHD, Study chair, KU LeuvenMike Polkey, MD, PHD, Study chair, Royal Brompton & Harefield NHS Foundation TrustJudith Garcia-Aymerich, MD, PHD, Study chair, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158065
- Sponsor's protocol ID
- ML9814
- Acronym
- MrPAPP
- Status last verified
- Apr 2015
- First submitted
- 5 Jun 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30578215Demeyer 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.
PubMed 28137918
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02158065
- Acronym / sponsor ID
- MrPAPP / ML9814
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease (COPD), physical activity, PROactive, telecoaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University of Edinburgh, Royal Brompton & Harefield NHS Foundation Trust, University Medical Center Groningen, University of Athens, University of Zurich, Barcelona Institute for Global Health
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status |
| Coaching program | Experimental | Other: Coaching programIn addition to usual care, patients will receive the coaching program |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching programThe 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. | Other | Coaching program |
Primary outcome
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).
5 secondary outcomes
Time spent in at least moderate physical activity
Time frame: changes from baseline to 3 months
Proportion of patients showing an increase of physical activity by >20%
Time frame: changes from baseline to 3 months
6-minute walking test
Time frame: changes from baseline to 3 months
isometric Quadriceps force
Time frame: changes from baseline to 3 months
COPD symptoms and health-related quality of life
Time frame: changes form baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Derived from this study: PubMed 30578215Loeckx 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.
- Derived from this study: PubMed 28137918Demeyer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Troosters, PT, PHD study chair
KU Leuven
Mike Polkey, MD, PHD study chair
Royal Brompton & Harefield NHS Foundation Trust
Judith Garcia-Aymerich, MD, PHD study chair
Barcelona Institute for Global Health
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching program in people with Pulmonary Disease, Chronic Obstructive, run by KU Leuven at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Belgium, Greece, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily number of steps (time frame: changes from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02158065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.