Effectiveness of Standardized Respiratory Physiotherapy in Primary Care

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

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.

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Procedure: Standardized Respiratory Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43202
      • Catalan Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized Respiratory Physiotherapy; Standardized Respiratory Physiotherapy is the intervention in all selected patients	Procedure: Standardized Respiratory Physiotherapy; Standardized Respiratory Physiotherapy during 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. George's Respiratory Questionnaire	Quality of life Questionnaire	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BODE index	Is a complex index that measures dyspnea, FEV1, BMI, and six-minute walk distance	Six months

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Principal Investigator: Maria Montserrat Ingles Novell, Catalan Institute of Health

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 28, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Physiotherapy, COPD, effectiveness, primary care
• Other Study ID Numbers: P07/42