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Impact of "Telecoaching Program" on Physical Activity in Patients With COPD (MrPAPP)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Coaching program

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic obstructive pulmonary disease (COPD), physical activity, PROactive, telecoaching

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

KULeuven
Thorax Research Foundation
University Medical Center
University of Zurich
University of Edinburgh
Royal Brompton Hospital, Imperial College

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Coaching program

Arm Description

Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status

In addition to usual care, patients will receive the coaching program

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

6-minute walking test

isometric Quadriceps force

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

Full Information

NCT ID

NCT02158065

First Posted

June 5, 2014

Last Updated

April 30, 2015

Sponsor

KU Leuven

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

1. Study Identification

Unique Protocol Identification Number

NCT02158065

Brief Title

Impact of "Telecoaching Program" on Physical Activity in Patients With COPD

Acronym

MrPAPP

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

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease (COPD), physical activity, PROactive, telecoaching

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

370 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status

Arm Title

Coaching program

Arm Type

Experimental

Arm Description

In addition to usual care, patients will receive the coaching program

Intervention Type

Other

Intervention Name(s)

Coaching program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Daily number of steps

Description

Time Frame

changes from baseline to 3 months

Secondary Outcome Measure Information:

Title

Time spent in at least moderate physical activity

Description

Time Frame

changes from baseline to 3 months

Title

Proportion of patients showing an increase of physical activity by >20%

Description

Time Frame

changes from baseline to 3 months

Title

6-minute walking test

Time Frame

changes from baseline to 3 months

Title

isometric Quadriceps force

Time Frame

changes from baseline to 3 months

Title

COPD symptoms and health-related quality of life

Description

COPD symptoms and health-related quality of life will be measured by the CAT, CCQ, HADS and mMRC questionnaires

Time Frame

changes form baseline to 3 months

Other Pre-specified Outcome Measures:

Title

daily and clinic visit version of PROactive instrument

Time Frame

changes from baseline to 3 months

Title

Satisfaction with the telecoaching program

Description

Questionnaire and qualitative interview about the patients' experience

Time Frame

Information gathered after 3 months of intervention

Title

Compliance with the telecoaching program

Description

Compliance of wearing the step counter and performing the tasks of the smartphone interface

Time Frame

Information gathered after 3 months of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry Troosters, PT, PHD

Organizational Affiliation

KU Leuven

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mike Polkey, MD, PHD

Organizational Affiliation

Royal Brompton & Harefield NHS Foundation Trust

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Judith Garcia-Aymerich, MD, PHD

Organizational Affiliation

Barcelona Institute for Global Health

Official's Role

Study Chair

Facility Information:

Facility Name

KULeuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Thorax Research Foundation

City

Athens

Country

Greece

Facility Name

University Medical Center

City

Groningen

Country

Netherlands

Facility Name

University of Zurich

City

Zurich

Country

Switzerland

Facility Name

University of Edinburgh

City

Edinburgh

Country

United Kingdom

Facility Name

Royal Brompton Hospital, Imperial College

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30578215

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.

Results Reference

derived

PubMed Identifier

28137918

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.

Results Reference

derived

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Impact of "Telecoaching Program" on Physical Activity in Patients With COPD

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