Overview

This trial is active, not recruiting.

Condition copd
Treatment standardized respiratory physiotherapy
Sponsor Jordi Gol i Gurina Foundation
Start date September 2007
End date July 2008
Trial size 205 participants
Trial identifier NCT01152762, P07/42

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Standardized Respiratory Physiotherapy is the intervention in all selected patients
standardized respiratory physiotherapy
Standardized Respiratory Physiotherapy during 6 months

Primary Outcomes

Measure
St. George's Respiratory Questionnaire
time frame: Six months

Secondary Outcomes

Measure
BODE index
time frame: Six months

Eligibility Criteria

Male or female participants from 40 years up to 74 years old.

Inclusion Criteria: - Mild COPD diagnostic by GOLD criteria. - Absence of contraindications for walk tests and training. - Disponibility. - Age between 40 and 74 years old. Exclusion Criteria: - Patients with treatment of oxygen or domiciliary oxygen therapy. - Communication deficience(dementia, terminal illness, illiteracy). - Informed consent not available.

Additional Information

Official title Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment
Principal investigator Maria Montserrat Ingles Novell
Description AIMS 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. METHOD 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.