COPDFREAPNCT01152762

Effectiveness of Standardized Respiratory Physiotherapy in Primary Care (FREAP)

A study testing Standardized Respiratory Physiotherapy in people with COPD, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 74 years
Conditions the study is for: COPD
What is being tested?: Standardized Respiratory Physiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: 1 siteSpain
Study dates: Sep 2007to Jul 2011
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Catalan Health Institute
Reus, Tarragona, 43202

Other trials in Spain

About this study

Official title: 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.

Read the 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
Being tested: Standardized Respiratory Physiotherapy, Placebo - Primary care procedure
Keywords: Physiotherapy, COPD, effectiveness, primary care
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standardized Respiratory PhysiotherapyProcedure or surgery
Standardized Respiratory Physiotherapy during 6 months
Placebo - Primary care procedureProcedure or surgery
Usual clinical practice.

Study groups in NCT01152762
Study group	Role	What they receive
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. Receives: Procedure: Standardized Respiratory Physiotherapy
Placebo	Placebo comparator	Usual clinical practice. Receives: Procedure: Placebo - Primary care procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Jul 2011

First posted29 Jun 2010 (estimated)
Study startSep 2007
Primary completionJul 2008
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152762
Sponsor's protocol ID: P07/42
Acronym: FREAP
Status last verified: Feb 2023
First submitted: 28 Jun 2010
Last updated: 6 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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