Sustaining Training Effects Through Physical Activity (STEP)

October 23, 2019 updated by: Thierry Troosters, KU Leuven

Enhancing Physical Activity to Achieve Sustainable Benefits in Extrapulmonary Consequences of COPD

This randomized control trial will investigate whether the implementation of a telecoaching program, initiated during pulmonary rehabilitation, is able to increase and maintain physical activity and general benefits until six months after rehabilitation discharge.

After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be randomized to either an intervention group which receives an additional telecoaching program on top of the pulmonary rehabilitation, or to the usual care group, which only receives rehabilitation program. Apart from the added telecoaching program to the intervention group, the rehabilitation program will be identical and last for another three months (2 times a week). After discharge, both groups will be followed up for six months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a primary diagnosis of COPD according to internationally accepted guidelines
  • Patients that completed three months of the outpatient pulmonary rehabilitation program of Gasthuisberg University Hospital (Leuven, Belgium)
  • Current or previous smoking exposure of at least 10 pack years
  • Ability to manage electronic devices (smartphone, step counter)

Exclusion Criteria:

  • Other predominant respiratory diseases than COPD (asthma, pulmonary hypertension)
  • Orthopedic, neurological and muscular co morbidities that could interfere with normal biomechanical movement patterns and the ability to increase physical activity levels
  • Patients on the waiting list for lung transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Telecoaching - feasible goal setting and feedback to enhance patient's motivation and commitment - in addition to pulmonary rehabilitation.
Behavioral: Telecoaching
Pedeometer based goals and telecoaching support
Other: pulmonary rehabilitation
Conventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months.
Other: Usual care
includes only general advices regarding physical activity.
Other: pulmonary rehabilitation
Conventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in physical activity (number of steps)
Time Frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
At three and six months of pulmonary rehabilitation and three and six months of follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in physical activity (time spent in moderate activity)
Time Frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Quadriceps force)
Time Frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)
Time Frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)
Time Frame: At three and six months of pulmonary rehabilitation and six months of follow up
At three and six months of pulmonary rehabilitation and six months of follow up
Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)
Time Frame: At three and six months of pulmonary rehabilitation and six months of follow up
At three and six months of pulmonary rehabilitation and six months of follow up
Changes in pulmonary rehabilitation outcomes (Quality of life)
Time Frame: At three and six months of pulmonary rehabilitation and six months of follow up
At three and six months of pulmonary rehabilitation and six months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Thierry Troosters, PhD, Katholiek universiteit Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s57963

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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