Sustaining Training Effects Through Physical Activity

Pulmonary Disease, Chronic Obstructive Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702791
• Other study ID #: s57963
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Telecoaching
Pedeometer based goals and telecoaching support

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

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in physical activity (number of steps)		At three and six months of pulmonary rehabilitation and three and six months of follow up
Secondary	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
Secondary	Changes in pulmonary rehabilitation outcomes (Quadriceps force)		At three and six months of pulmonary rehabilitation and three and six months of follow up
Secondary	Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)		At three and six months of pulmonary rehabilitation and three and six months of follow up
Secondary	Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)		At three and six months of pulmonary rehabilitation and six months of follow up
Secondary	Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)		At three and six months of pulmonary rehabilitation and six months of follow up
Secondary	Changes in pulmonary rehabilitation outcomes (Quality of life)		At three and six months of pulmonary rehabilitation and six months of follow up