Pulmonary Rehabilitation Program and PROactive Tool

NCT02437994 | Unknown

• 1 other identifier: 933
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Proactive tool (clinical visit version)

  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.

  7 days

Secondary Outcomes (1)

• Daily Physical activity as measured by a validated for COPD patients triaxial accelerometers

  7 days

Study Arms (2)

Pulmonary Rehabilitation

EXPERIMENTAL

The rehabilitation program will be multidisciplinary and will include supervised exercise training (interval exercise and resistance exercises), breathing control and relaxation techniques, methods of clearance of pulmonary secretions, disease education, dietary advice, and psychological support on issues relating to chronic disability.

Behavioral: Pulmonary Rehabilitation

Control

NO INTERVENTION

In addition, a control group (Group C) which will not participate in the rehabilitation program (usual care) will be include at the same time as patients in Group A and B so as to be able and independently address study objectives 2 and 3 and 4. Group C will also randomized to those into paper-pencil version and electronic version.

Interventions

Pulmonary Rehabilitation BEHAVIORAL

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.

Pulmonary Rehabilitation

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thorax Research Foundation: lead

Study Sites (1)

Pulmonary Rehabilitation Centre, Sotiria Hospital, 1st Departments of Respiratory Medicine, National and Kapodistrian University of Athens

Athens, Greece

Location

Related Publications (2)

• 1. Nici L. American Thoracic Society/ Respiratory Society statement of pulmonary rehabilitation. American Journal Respiratory Critical Care Medicine 173: 1390-1413, 2006. 2. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Executive summary. 2005 3. Rabe K.F. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. American Journal Respiratory Critical Care Medicine 176: 532-555, 2007. 4. Charloux A. Exercise by a new impedance cardiography device: comparison with the direct Fick method. European of Applied Physiology 82: 313-320, 2000.

  BACKGROUND

• Louvaris Z, Spetsioti S, Kortianou EA, Vasilopoulou M, Nasis I, Kaltsakas G, Koulouris NG, Vogiatzis I. Interval training induces clinically meaningful effects in daily activity levels in COPD. Eur Respir J. 2016 Aug;48(2):567-70. doi: 10.1183/13993003.00679-2016. Epub 2016 Jun 23. No abstract available.

  PMID: 27338191 DERIVED

Related Links

• Thorax Research Foundation

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CHARALAMBOS ROUSSOS, PhD, MD

  Thorax Research Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invetsigator

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 8, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

GR (1)