Clinical trial NCT01152762: Effectiveness of Standardized Respiratory Physiotherapy in Primary Care
Official title: Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: Physiotherapy, COPD, effectiveness, primary care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 205
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: St. George's Respiratory Questionnaire
timeFrame: Six months
Secondary outcomes:
measure: BODE index
timeFrame: Six months
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Catalan Health Institute
state: Tarragona
Study officials:
affiliation: Catalan Institute of Health
name: Maria Montserrat Ingles Novell
role: PRINCIPAL_INVESTIGATOR
References: