Effectiveness of Standardized Respiratory Physiotherapy in Primary Care (FREAP)

NCT01152762 | Completed Results

• 1 other identifier: P07/42
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Physiotherapy, COPD, effectiveness, primary care

Outcome Measures

Primary Outcomes (2)

• St-George Respiratory Questionnaire-SGRQ

  The questionnaire is designed to measure the impact of respiratory symptoms and their treatment on a patient's daily life. It consists of various sections that cover a range of topics related to respiratory health, including symptoms, activity limitations, and overall well-being. The SGRQ questionnaire has 50 items with 76 weighted responses. Scores range from 0 to 100, with higher scores indicating more limitations.

  Six months

• BODE Index

  The BODE index is a clinical tool used to assess the severity of chronic obstructive pulmonary disease (COPD) and predict the risk of mortality in individuals with this respiratory condition. The BODE Index is a 0 to 10-point scale and it is based on four factors: * Body Mass Index (BMI) * Airflow obstruction (FEV1, as a percentage of the predicted value) * Dyspnea (measured using the MRC dyspnea scale, which ranges from 0 to 4) * Exercise capacity (measured by the 6-minute walk test, in meters) Each factor is assigned a score from 0 to 3 (except for BMI, which can only receive 0 or 1). The total score ranges from 0 to 10, with higher values indicating greater severity and a worse prognosis for COPD.

  6 month

Study Arms (2)

Standardized Respiratory Physiotherapy

EXPERIMENTAL

Standardized Respiratory Physiotherapy is the intervention in all selected patients. 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.

Procedure: Standardized Respiratory Physiotherapy

Placebo

PLACEBO COMPARATOR

Usual clinical practice.

Procedure: Placebo - Primary care procedure

Interventions

Standardized Respiratory Physiotherapy PROCEDURE

Standardized Respiratory Physiotherapy during 6 months

Standardized Respiratory Physiotherapy

Placebo - Primary care procedure PROCEDURE

Usual clinical practice.

Placebo

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild COPD diagnostic by GOLD criteria.
• Absence of contraindications for walk tests and training.
• Disponibility.
• Age between 40 and 74 years old.

You may not qualify if:

• Patients with treatment of oxygen or domiciliary oxygen therapy.
• Communication deficience(dementia, terminal illness, illiteracy).
• Informed consent not available.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Catalan Health Institute

Reus, Tarragona, 43202, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Maria Montserrat Inglés Novell
• Organization: Catalan Health Institute

cborau@idiapjgol.org

+34 977252808

Study Officials

• Maria Montserrat Ingles Novell

  Catalan Institute of Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: September 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2011
• Last Updated: August 6, 2026
• Results First Posted: August 6, 2026

Record last verified: 2023-02

Locations

ES (1)