Clinical trial NCT02702791: Sustaining Training Effects Through Physical Activity
Official title: Enhancing Physical Activity to Achieve Sustainable Benefits in Extrapulmonary Consequences of COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Physical activity
Pulmonary rehabilitation
COPD
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-03-09
Enrollment: 73
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in physical activity (number of steps)
timeFrame: At three and six months of pulmonary rehabilitation and three and six months of follow up
Secondary outcomes:
measure: Changes in physical activity (time spent in moderate activity)
timeFrame: At three and six months of pulmonary rehabilitation and three and six months of follow up
measure: Changes in pulmonary rehabilitation outcomes (Quadriceps force)
timeFrame: At three and six months of pulmonary rehabilitation and three and six months of follow up
measure: Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)
timeFrame: At three and six months of pulmonary rehabilitation and three and six months of follow up
measure: Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)
timeFrame: At three and six months of pulmonary rehabilitation and six months of follow up
measure: Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)
timeFrame: At three and six months of pulmonary rehabilitation and six months of follow up
measure: Changes in pulmonary rehabilitation outcomes (Quality of life)
timeFrame: At three and six months of pulmonary rehabilitation and six months of follow up
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams Brabant
Study officials:
affiliation: Katholiek Universiteit Leuven
name: Thierry Troosters, PhD
role: PRINCIPAL_INVESTIGATOR
References: