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Effectiveness of Standardized Respiratory Physiotherapy in Primary Care (FREAP)

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01152762
Acronym
FREAP
Enrollment
129
Registered
2010-06-29
Start date
2007-09-01
Completion date
2011-07-01
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

Physiotherapy, COPD, effectiveness, primary care

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.

Interventions

PROCEDUREStandardized Respiratory Physiotherapy

Standardized Respiratory Physiotherapy during 6 months

PROCEDUREPlacebo - Primary care procedure

Usual clinical practice.

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
St-George Respiratory Questionnaire-SGRQSix monthsThe 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.
BODE Index6 monthThe 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.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORMaria Montserrat Ingles Novell

Catalan Institute of Health

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
38 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
Age, Continuous60.4 years
STANDARD_DEVIATION 8.3
Region of Enrollment
Spain
65 participants
Sex: Female, Male
Female
35 Participants
Sex: Female, Male
Male
51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 620 / 60
other
Total, other adverse events
0 / 620 / 60
serious
Total, serious adverse events
0 / 620 / 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026