NCT01152762

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

10 months

First QC Date

June 28, 2010

Last Update Submit

June 28, 2010

Conditions

Keywords

Physiotherapy, COPD, effectiveness, primary care

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

EXPERIMENTAL

Standardized Respiratory Physiotherapy is the intervention in all selected patients

Procedure: Standardized Respiratory Physiotherapy

Interventions

Standardized Respiratory Physiotherapy during 6 months

Standardized Respiratory Physiotherapy

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Montserrat Ingles Novell

    Catalan Institute of Health

    PRINCIPAL INVESTIGATOR

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

Locations