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Sustaining Training Effects Through Physical Activity (STEP)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Telecoaching

pulmonary rehabilitation

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Physical activity, Pulmonary rehabilitation, COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Usual care

Arm Description

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

includes only general advices regarding physical activity.

Outcomes

Primary Outcome Measures

Changes in physical activity (number of steps)

Secondary Outcome Measures

Changes in physical activity (time spent in moderate activity)

Changes in pulmonary rehabilitation outcomes (Quadriceps force)

Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)

Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)

Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)

Changes in pulmonary rehabilitation outcomes (Quality of life)

Full Information

NCT ID

NCT02702791

First Posted

January 12, 2016

Last Updated

October 23, 2019

Sponsor

KU Leuven

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT02702791

Brief Title

Sustaining Training Effects Through Physical Activity

Acronym

STEP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

October 2015 (Actual)

Primary Completion Date

September 2019 (Actual)

Study Completion Date

October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Pulmonary Disease, Chronic Obstructive

Keywords

Physical activity, Pulmonary rehabilitation, COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Usual care

Arm Type

Other

Arm Description

includes only general advices regarding physical activity.

Intervention Type

Behavioral

Intervention Name(s)

Telecoaching

Intervention Description

Pedeometer based goals and telecoaching support

Intervention Type

Other

Intervention Name(s)

pulmonary rehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)

Time Frame

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

Title

Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)

Time Frame

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

Title

Changes in pulmonary rehabilitation outcomes (Quality of life)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry Troosters, PhD

Organizational Affiliation

Katholiek Universiteit Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Leuven

City

Leuven

State/Province

Vlaams Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

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