Effectiveness of Standardized Respiratory Physiotherapy in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Jordi Gol i Gurina Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01152762
First received: June 28, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention
COPD
Procedure: Standardized Respiratory Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Standardized Respiratory Physiotherapy in Primary Care in Patients With Mild COPD and Its Economic Assessment

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • St. George's Respiratory Questionnaire [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Quality of life Questionnaire


Secondary Outcome Measures:
  • BODE index [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Is a complex index that measures dyspnea, FEV1, BMI, and six-minute walk distance


Enrollment: 205
Study Start Date: September 2007
Estimated Study Completion Date: July 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standardized Respiratory Physiotherapy
Standardized Respiratory Physiotherapy is the intervention in all selected patients
Procedure: Standardized Respiratory Physiotherapy
Standardized Respiratory Physiotherapy during 6 months

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

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152762

Locations
Spain
Catalan Health Institute
Reus, Tarragona, Spain, 43202
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Principal Investigator: Maria Montserrat Ingles Novell Catalan Health Institute
  More Information

No publications provided

Responsible Party: Maria Montserrat Ingles Novell, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01152762     History of Changes
Other Study ID Numbers: P07/42
Study First Received: June 28, 2010
Last Updated: June 28, 2010
Health Authority: Jordi Gol i Gurina Foundation, Spain:

Keywords provided by Jordi Gol i Gurina Foundation:
Physiotherapy, COPD, effectiveness, primary care

ClinicalTrials.gov processed this record on October 23, 2014