Effectiveness of Standardized Respiratory Physiotherapy in Primary Care

NCT ID: NCT01152762

Last Updated: 2010-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-07-31

Brief 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.

Detailed 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.

Conditions

COPD

Keywords

Physiotherapy, COPD, effectiveness, primary care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standardized Respiratory Physiotherapy

Standardized Respiratory Physiotherapy is the intervention in all selected patients

Group Type: EXPERIMENTAL

Standardized Respiratory Physiotherapy

Intervention Type: PROCEDURE

Standardized Respiratory Physiotherapy during 6 months

Interventions

Standardized Respiratory Physiotherapy

Standardized Respiratory Physiotherapy during 6 months

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Jordi Gol i Gurina Foundation

Principal Investigators

Maria Montserrat Ingles Novell

Role: PRINCIPAL_INVESTIGATOR

Catalan Institute of Health

Locations

Catalan Health Institute

Reus, Tarragona, Spain

Countries

Spain

Other Identifiers

P07/42

Identifier Type: -

Identifier Source: org_study_id