Sustaining Training Effects Through Physical Activity

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Behavioral: Telecoaching
* Other: pulmonary rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Changes in pulmonary rehabilitation outcomes (Quality of life) |  | At three and six months of pulmonary rehabilitation and six months of follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Pulmonary rehabilitation, COPD