Effectiveness of Standardized Respiratory Physiotherapy in Primary Care
|ClinicalTrials.gov Identifier: NCT01152762|
Recruitment Status : Unknown
Verified June 2010 by Jordi Gol i Gurina Foundation.
Recruitment status was: Active, not recruiting
First Posted : June 29, 2010
Last Update Posted : June 29, 2010
Chronic Obstructive Pulmonary Disease (COPD) is a very important public health problem and one of the most common lung diseases in the world, with repercussions on mortality and high economic costs. The World Health Organization estimates that COPD is the fifth most common disease in the world and the fourth leading cause of death. It is expected to grow in prevalence and mortality over the coming decades; it is estimated that in 2020, it will be the third most common cause of death worldwide.
Primary care is the main ambit in the management of these patients, in fact, it is where most patients with COPD are visited. However, a high proportion of these patients only receive chest physiotherapy treatment in hospitals, and the implementation of this kind of treatment in primary care is still very uncommon.
Hypothesis: There is effectiveness on the quality of life and various predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care (FREAP) in patients with moderate COPD at 6 months after its implementation.
|Condition or disease||Intervention/treatment||Phase|
|COPD||Procedure: Standardized Respiratory Physiotherapy||Not Applicable|
To evaluate the effectiveness on the quality of life and various predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care (FREAP) in patients with moderate COPD at 6 months after its implementation.
Design: Randomized controlled trial
Location: Tarragona-Reus Primary Care Area of the Catalan Health Service. 14 primary care centres were involved in the project (8 from the Reus-Altebrat Primary Care Service and 6 from the Tarragona-Valls Primary Care Service) and 8 units of physiotherapy.
Participants: 129 patients with moderate COPD treated by primary care teams.
Intervention: FREAP program for 6 months. It consisted of an initial health education session conducted in the primary care health centre, three sessions a week for three weeks of breathing exercises and aerobic, physical training in the primary care health centre and a monthly monitoring appointment for the breathing exercises and training for five months in the patient's home. Altogether, 10 sessions in the primary care health center and 5 sessions at the patients' house. Patients randomized in the control group continued with their usual clinical practice.
Main effect measures: Quality of life (St. George Respiratory Questionnaire -SGRQ-). Predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index). Economic cost of implementing the FREAP program.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2008|
|Estimated Study Completion Date :||July 2010|
Experimental: Standardized Respiratory Physiotherapy
Standardized Respiratory Physiotherapy is the intervention in all selected patients
Procedure: Standardized Respiratory Physiotherapy
Standardized Respiratory Physiotherapy during 6 months
- St. George's Respiratory Questionnaire [ Time Frame: Six months ]Quality of life Questionnaire
- BODE index [ Time Frame: Six months ]Is a complex index that measures dyspnea, FEV1, BMI, and six-minute walk distance
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152762
|Catalan Health Institute|
|Reus, Tarragona, Spain, 43202|
|Principal Investigator:||Maria Montserrat Ingles Novell||Catalan Institute of Health|