Impact of a Pulmonary Rehabilitation Program on the PROactive Tool
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Proactive tool (clinical visit version)
Study Overview
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.
Detailed Description
Study hypotheses
The patients involved during Work Package 4 of the PROactive Project showed a good conformity with the use of electronic devices such as the electronic version of the PROactive tool. As the paper-pencil version is anticipated to be equally easy to manage from the patients as the electronic version, therefore it is expected an excellent agreement between the paper-pencil and the electronic version in terms of assessing the effect of pulmonary rehabilitation on the components of the PROactive tool.
A pulmonary rehabilitation program of at least 8-10 weeks is considered sufficient to induce reduction in daily and exercise induced symptoms, improvements in functional capacity and exercise tolerance and increase in health related quality of life in patients with COPD. Since low levels of physical activity are associated with reduced exercise performance and increased daily symptoms, it is anticipated a significant improvements in daily physical activity levels (as measured by daily number of steps, vector magnitude unit and movement intensity) and in the components of the Pro-Active tool following the completion of the pulmonary rehabilitation program.
Recent published studies funded form PROactive Project revealed that activity monitoring outputs are associated with the cardiovascular, respiratory, and metabolic load of exercise in COPD patients. Therefore it is expected to found significant associations between daily physical activity levels and the components of the PROactive tool in general with functional capacity, exercise capacity and cardio-respiratory adaptations following completion of a comprehensive pulmonary rehabilitation program.
Study population
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically stable patients with COPD will be recruited from the academic centers' Outpatient Clinic on the following entry criteria:
- •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
- •optimal medical therapy according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) (6).
Exclusion Criteria
- •Orthopedic, neurological, and other musculoskeletal complaints that could impair normal movement patterns,
- •respiratory diseases other than COPD (e.g. asthma),
- •hospital admission or COPD exacerbations within the previous 4 weeks
- •patients not on optimal pharmacotherapy.
Outcomes
Primary Outcomes
Proactive tool (clinical visit version)
Time Frame: 7 days
Proactive tool is a patient-reported outcome which combines a 12-item self-administrated questionnaire and activity monitor score in order to assess daily physical activity in patients with COPD. Proactive tool can be scored as a simple sum of the scores of the items (each item can be scored mostly from 0 to 4), with lower scores indicating poorer physical activity.
Secondary Outcomes
- Daily Physical activity as measured by a validated for COPD patients triaxial accelerometers(7 days)
Investigators
IOANNIS VOGIATZIS
Principal Invetsigator
Thorax Research Foundation