We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02158065
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : May 1, 2015
Sponsor:
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
Information provided by (Responsible Party):
Thierry Troosters, KU Leuven

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: Coaching program Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Usual care
Patients will receive information (leaflet) and guidance on the benefits associated with increased physical activity in COPD patients and their health status
Experimental: Coaching program
In addition to usual care, patients will receive the coaching program
 Other: Coaching 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time spent in at least moderate physical activity [ Time Frame: 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).

  2. Proportion of patients showing an increase of physical activity by >20% [ Time Frame: 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).

  3. 6-minute walking test [ Time Frame: changes from baseline to 3 months ]
  4. isometric Quadriceps force [ Time Frame: changes from baseline to 3 months ]
  5. COPD symptoms and health-related quality of life [ Time Frame: 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


Other Outcome Measures:
  1. daily and clinic visit version of PROactive instrument [ Time Frame: changes from baseline to 3 months ]
  2. Satisfaction with the telecoaching program [ Time Frame: Information gathered after 3 months of intervention ]
    Questionnaire and qualitative interview about the patients' experience

  3. Compliance with the telecoaching program [ Time Frame: Information gathered after 3 months of intervention ]
    Compliance of wearing the step counter and performing the tasks of the smartphone interface


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158065


Locations
Layout table for location information
Belgium
KULeuven
Leuven, Belgium, 3000
Greece
Thorax Research Foundation
Athens, Greece
Netherlands
University Medical Center
Groningen, Netherlands
Switzerland
University of Zurich
Zurich, Switzerland
United Kingdom
University of Edinburgh
Edinburgh, United Kingdom
Royal Brompton Hospital, Imperial College
London, United Kingdom
Sponsors and Collaborators
KU Leuven
University of Edinburgh
Royal Brompton & Harefield NHS Foundation Trust
University Medical Center Groningen
University of Athens
University of Zurich
Barcelona Institute for Global Health
Investigators
Layout table for investigator information
Study Chair: Thierry Troosters, PT, PHD KU Leuven
Study Chair: Mike Polkey, MD, PHD Royal Brompton & Harefield NHS Foundation Trust
Study Chair: Judith Garcia-Aymerich, MD, PHD Barcelona Institute for Global Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Thierry Troosters, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT02158065    
Other Study ID Numbers: ML9814
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Thierry Troosters, KU Leuven:
Chronic obstructive pulmonary disease (COPD)
physical activity
PROactive
telecoaching
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Chronic Disease
 Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive