Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of a Pulmonary Rehabilitation Program on the PROactive Tool
Brief Summary: Pulmonary rehabilitation is an essential non pharmacological treatment option which reduces dyspnea sensations, increase exercise tolerance, improves health related quality of life and reduces the burden on health care resources (1). Pulmonary rehabilitation is likely an ideal intervention to validate the PROactive tool as responses to pulmonary rehabilitation are clinically significant in terms of exercise tolerance and particularly activity related symptoms. Nevertheless, the response to pulmonary rehabilitation is variable and about one out of three patients does not present a clinically important response. Pulmonary rehabilitation may therefore be an intervention that allows studying the conceptual model around the PROactive tools, anchoring the new PROs (Patient Report Outcome) to outcomes that are well known to change with rehabilitation: exercise induced symptoms, functional exercise tolerance and health related quality of life.

Study objectives

Main objectives

A primary aim is to test reliability of the paper-pencil versus the electronic scoring version of the PROactive tool in terms of assessing the effect of pulmonary rehabilitation on the components of the PROactive tool and on the mode of administration.

The secondary aim of the proposed project is to investigate the effects of a multidisciplinary outpatient hospital-based, pulmonary rehabilitation program on: i) daily physical activity (number of daily steps, vector magnitude unit and movement intensity and ii) the components of the Proactive tool.

Additional study objectives

A third aim of this project is to investigate whether the magnitude of change in daily physical activity and the components of the PROactive tool in general is associated with the magnitude of changes in frequently used rehabilitation related end-points including, functional capacity, exercise capacity and health-related quality of life following the completion of a comprehensive pulmonary rehabilitation program.

A forth aim of this project is to investigate whether the magnitude of change in daily physical activity and the components of the PROactive tool in general is associated with the magnitude of changes in physiological indices including cardiovascular and respiratory adaptations following completion of a comprehensive pulmonary rehabilitation program.


Options:
A: Inclusion Criteria:

Clinically stable patients with COPD will be recruited from the academic centers' Outpatient Clinic on the following entry criteria:

1. a post-bronchodilator forced expiratory volume in one second (FEV1) \<70% predicted without significant reversibility (\<12% change of the initial FEV1 value or \<200 ml) and
2. optimal medical therapy according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) (6).

Exclusion Criteria:

1. Orthopedic, neurological, and other musculoskeletal complaints that could impair normal movement patterns,
2. respiratory diseases other than COPD (e.g. asthma),
3. hospital admission or COPD exacerbations within the previous 4 weeks
4. patients not on optimal pharmacotherapy.
B: Inclusion Criteria:

To be eligible for inclusion in this study Patients fulfil all of the following criteria:

1. Written informed consent obtained before any assessment is performed.
2. Male and female patients ≥ 40 years of age
3. Diagnosis of COPD \[post-bronchodilator forced expiratory volume at one second (FEV1) \<80% predicted and FEV1/ forced vital capacity (FVC) \<75% without significant post-bronchodilator reversibility (\<10% FEV1 % predicted normal)\]
4. Optimal medical treatment according to GOLD without regular use of systemic corticosteroids
5. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
6. Absence of other significant diseases that could contribute to exercise limitation
7. At least 2 COPD exacerbations the year before the time entry

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions are applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

1. Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased.
2. Respiratory diseases other than COPD (e.g. asthma)
3. Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the tablet, as judged by the investigator
4. Patients not on optimal pharmacotherapy
5. No COPD exacerbations the year before the time entry
C: Inclusion Criteria:

* Diagnosis of COPD
* At least one COPD-related hospitalization or COPD-related emergency department presentation in the previous 12 months to enrollment
* Capable to provide signed written informed consent

Exclusion Criteria:

* Attendance to a rehabilitation program in the previous 6 months of enrollment
* Participation in another study that may have an impact on the outcome of this study
* Deemed by the health care team to be physically uncapable to perform the study procedures
* Presence of comorbidities wich might prevent the patient from safely undertake an exercise program at home
* Home environment not suitable for installation and use of rehabilitation and monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)
D: Inclusion Criteria:

* current or former smokers of at least 10 packet years
* aged 40 years or over
* diagnosis of COPD confirmed on spirometry.

Exclusion Criteria:

* previous diagnosis of asthma
* have attended a pulmonary rehabilitation program in the last two years
* exacerbation of COPD within the last four weeks
* have comorbidities which prevent participation in an exercise training program

Answer: A