Chronic Obstructive Pulmonary Disease Respiratory Other chronic obstructive pulmonary disease
Conditions
Interventions
Patients in the two intervention groups will receive a pulmonary rehabilitation programme of three, 90 minutes weekly sessions during 12 weeks. The sessions consist of four types of interventions:
1.
Sponsors
TV3 Marathon Foundation (Fundació La Marató de TV3) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Patients with severe and very mild COPD 2. FEV180% 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life: 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
| Measure | Time frame |
|---|---|
| 1. The 6-min-walking test: Conducted along a flat corridor during 25 minutes. Each patient will be instructed and receive standarised encouragement to walk from one end to the other, covering as much ground as possible during the allotted time, as recomended by the American Thoracic Society. 2. Patients will rate their level of dyspnoea in daily activities through the Dyspnoea Index (Borg scale): A 10cm visual analogue scale bounded by the descriptors 'no shortness of breath at all' and 'maximum shortness of breath' and using the Medical Research Council (MRC) scale which specifies eight levels of dyspnoea. 3. Lung function testing: Including forced spirometry with bronchodilator test with a Datospir 120 spirometer following Spanish Society of Pneumology and Thoracic Surgery (SEPAR) recommendations for the values of FVC, FEV1, FEV1/FVC and Finite Element Model (FEM). 4. Number of hospital admissions and length of stay: By patient information. This information will be validated through hospital medical records. 5. Number of severe exacerbations: Defined as episodes of either dyspnoea or dry or productive cough, whether sputum was purulent or not, treated with oral corticoids and/or antibiotics requiring hospital admission. | — |
Countries
Spain
Outcome results
None listed