Effectiveness of Standardized Respiratory Physiotherapy in Primary Care
1 other identifier
interventional
205
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJune 29, 2010
June 1, 2010
10 months
June 28, 2010
June 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
St. George's Respiratory Questionnaire
Quality of life Questionnaire
Six months
Secondary Outcomes (1)
BODE index
Six months
Study Arms (1)
Standardized Respiratory Physiotherapy
EXPERIMENTALStandardized Respiratory Physiotherapy is the intervention in all selected patients
Interventions
Standardized Respiratory Physiotherapy during 6 months
Eligibility Criteria
You may qualify if:
- Mild COPD diagnostic by GOLD criteria.
- Absence of contraindications for walk tests and training.
- Disponibility.
- Age between 40 and 74 years old.
You may not qualify if:
- Patients with treatment of oxygen or domiciliary oxygen therapy.
- Communication deficience(dementia, terminal illness, illiteracy).
- Informed consent not available.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catalan Health Institute
Reus, Tarragona, 43202, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Montserrat Ingles Novell
Catalan Institute of Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 28, 2010
First Posted
June 29, 2010
Study Start
September 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2010
Last Updated
June 29, 2010
Record last verified: 2010-06