Pulmonary Rehabilitation Program and PROactive Tool

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

BEHAVIORAL

Pulmonary Rehabilitation

The rehabilitation program will be multidisciplinary and will include mandatory supervised exercise training at appropriate training intensity, other components of the program can be breathing control and relaxation techniques, methods of clearance of pulmonary secretions, disease education, dietary advice, and psychological support on issues relating to chronic disability. Six minute walking tests, and improvements in dyspnea sensation (CRDQ) will be used to benchmark the effect of a program provided by a given team.

Sponsors & Collaborators

• Thorax Research Foundation

  lead OTHER

Principal Investigators

• CHARALAMBOS ROUSSOS, PhD, MD · Thorax Research Foundation

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• Greece

Study Locations