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Completed

NCT Number: NCT02158065

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KULeuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coaching program

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Barcelona Institute for Global Health
  • Royal Brompton & Harefield NHS Foundation Trust
  • University Medical Center Groningen
  • University of Athens
  • University of Edinburgh
  • University of Zurich

Registry information

Official study 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)

Acronym: MrPAPP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2014
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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