NCT02702791

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

3.9 years

First QC Date

January 12, 2016

Last Update Submit

October 23, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Physical activityPulmonary rehabilitationCOPD

Outcome Measures

Primary Outcomes (1)

  • Changes in physical activity (number of steps)

    At three and six months of pulmonary rehabilitation and three and six months of follow up

Secondary Outcomes (6)

  • Changes in physical activity (time spent in moderate activity)

    At three and six months of pulmonary rehabilitation and three and six months of follow up

  • Changes in pulmonary rehabilitation outcomes (Quadriceps force)

    At three and six months of pulmonary rehabilitation and three and six months of follow up

  • Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)

    At three and six months of pulmonary rehabilitation and three and six months of follow up

  • Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)

    At three and six months of pulmonary rehabilitation and six months of follow up

  • Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)

    At three and six months of pulmonary rehabilitation and six months of follow up

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Telecoaching - feasible goal setting and feedback to enhance patient's motivation and commitment - in addition to pulmonary rehabilitation.

Behavioral: TelecoachingOther: pulmonary rehabilitation

Usual care

OTHER

includes only general advices regarding physical activity.

Other: pulmonary rehabilitation

Interventions

TelecoachingBEHAVIORAL

Pedeometer based goals and telecoaching support

Intervention
pulmonary rehabilitationOTHER

Conventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months.

InterventionUsual care

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

  • Loeckx M, Rodrigues FM, Blondeel A, Everaerts S, Janssens W, Demeyer H, Troosters T. Sustaining training effects through physical activity coaching (STEP): a randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Oct 10;20(1):121. doi: 10.1186/s12966-023-01519-w.

    PMID: 37814266DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Thierry Troosters, PhD

    Katholiek Universiteit Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

January 12, 2016

First Posted

March 9, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

BE(1)