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.
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. Read more about this study
- 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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Montserrat Ingles Novell, Principal investigator, Catalan Institute of Health
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment
- ClinicalTrials.gov ID
- NCT01152762
- Acronym / sponsor ID
- FREAP / P07/42
- Conditions
- COPD
- Keywords
- Physiotherapy, COPD, effectiveness, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Respiratory Physiotherapy | Experimental | Procedure: Standardized Respiratory PhysiotherapyStandardized 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. |
| Placebo | Placebo comparator | Procedure: Placebo - Primary care procedureUsual clinical practice. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild COPD diagnostic by GOLD criteria.
- Absence of contraindications for walk tests and training.
- Disponibility.
- Age between 40 and 74 years old.
Key exclusion criteria (3 listed)
- Patients with treatment of oxygen or domiciliary oxygen therapy.
- Communication deficience(dementia, terminal illness, illiteracy).
- Informed consent not available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Respiratory PhysiotherapyStandardized Respiratory Physiotherapy during 6 months | Procedure or surgery | Standardized Respiratory Physiotherapy |
| Placebo - Primary care procedureUsual clinical practice. | Procedure or surgery | Placebo |
Primary outcome
St-George Respiratory Questionnaire-SGRQ
Time frame: Six months
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.
BODE Index
Time frame: 6 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Montserrat Ingles Novell principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St-George Respiratory Questionnaire-SGRQ (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.