Effectiveness of Standardized Respiratory Physiotherapy in Primary Care

COPD Clinical Trial

Official title:

Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01152762
• Other study ID #: P07/42
• Status: Unknown status
• Phase: N/A
• First received: June 28, 2010
• Last updated: June 28, 2010
• Start date: September 2007
• Est. completion date: July 2010

Study information

• Verified date: June 2010
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 205
• Est. completion date: July 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Procedure:
• Standardized Respiratory Physiotherapy
Standardized Respiratory Physiotherapy during 6 months

Locations

Country	Name	City	State
Spain	Catalan Health Institute	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	St. George's Respiratory Questionnaire	Quality of life Questionnaire	Six months
Secondary	BODE index	Is a complex index that measures dyspnea, FEV1, BMI, and six-minute walk distance	Six months