Efficacy of pulmonary rehabilitation in moderate Chronic Obstructive Pulmonary Disease (COPD) patients in primary health care and maintenance of benefits at 2 years

Completed

Conditions: Chronic Obstructive Pulmonary Disease
Respiratory
Other chronic obstructive pulmonary disease

Registration Number: ISRCTN94514482

Lead Sponsor: TV3 Marathon Foundation (Fundació La Marató de TV3) (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 97

Inclusion Criteria

1. Clinical diagnosis of COPD with values of forced spirometry after broncodilatation of the ratio Forced Expiration Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) less than 0.7 and FEV1 between 30% and 80% of its reference values (Global Initiative for Chronic Obstructive Lung Disease [GOLD] criteria of moderate COPD).
2. Age between 35 and 74 years old.
3. No experience of exacerbation or hospital admission in the month before inclusion.
4. Willingness to participate in the study and signed informed consent.

Smoking will not be considered as an exclusion criterion.

Exclusion Criteria

1. Patients with severe and very mild COPD
2. FEV1<30% and >80%
3. Relevant osteoarticular disease or other debilitating diseases that could affect normal ambulation
4. Other important diseases that can impede follow-up (terminal patients, inmunodeficiencies, chronic infections)
5. Ischaemic heart disease, clinically evident, severe or uncontrolled systemic arterial hypertension.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life: <br>Assessed by the Spanish validated version of the Chronic Respiratory Questionnaire (CRQ) a 20 items scale, administered by an interviewer, designed for COPD patients. Each item is graded on 7-point likert scale. It includes four domains: dyspnoea (5 items), fatigue (4 items), emotional function (7 items) and mastery (4 items). It scores each dimension summing the punctuation of each item or through items average. The clinical repercussion of changes in the punctuation of CRQ after a therapeutic intervention (minimal important difference - MDCI) is 0.5 per item and 10 global scoring, a change of 2.5 in dyspnoea domain, 2 for fatigue and mastery and 3.5 for emotional function (Reardon J 1994). The questionnaire was adapted and validated by Güell et al (Güell R et al. Eur Respir J 1998; 11: 55-60.), showing good psychometric properties, high reliability and sensitivity to changes.

Secondary Outcome Measures