Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- St-George Respiratory Questionnaire-SGRQ
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Placebo
Usual clinical practice.
Intervention: Placebo - Primary care procedure (Procedure)
Standardized Respiratory Physiotherapy
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.
Intervention: Standardized Respiratory Physiotherapy (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported