Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Pulmonary Rehabilitation
Brief summary
OBJECTIVE: To determine whether a long-term maintenance program after respiratory rehabilitation, in contrast to the usual minimal maintenance therapy, improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations. MATERIAL AND METHODS: multi-center (4 hospitals) prospective randomized controlled study that will include 150 patients with moderate-severe COPD (age \<75; BODE 4-10) with a 3 years follow-up. All patients will receive an initial in-hospital rehabilitation program which includes: Education, Physiotherapy, lower and upper extremities training and respiratory muscles training. Following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies:1.-an intensive maintenance program (GR1) 2.- a standard, minimal monitoring program (GR2). On the intensive maintenance program (GR1) the physiotherapist will call once a week as a reminder and the patient will attend the hospital once a week . A physiotherapist will supervise the weekly in-hospital exercise and he/she will check if the patient is properly undergoing the rehabilitation treatment. OUTCOMES: 1.- Clinical: dyspnea (area of CRQ questionnaire), HRQL (CRQ, SF 36); Effort capacity (6minute Walking Test), BODE index; 2.- Economical: direct costs (programs); indirect costs (exacerbations, admissions); comparison of GR1 and GR2 costs; EXPECTED OUTCOMES: reduction of dyspnea, improvement of HRQL, effort capacity and BODE index, and reduction of health expenditures in GR1 compared to GR2.
Interventions
OTHERlong-term maintenance respiratory rehabilitation program
To determine whether a long-term maintenance program after respiratory rehabilitation (group active comparator), in contrast to the usual minimal maintenance therapy (group no intervention), improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 77 Years
Healthy volunteers
No
Inclusion criteria
* COPD Patients * Less than 77 years * BODE index of 3-10 (BODE 3 when FEV1\<50% v. Ref.). * clinically stable (at least one month) * Informed consent signed
Exclusion criteria
* Bone or muscle disease that limits the exercise training. * Heart disease that disable physic exercise. * Bronchiectasis or other Respiratory diseases different than COPD. * Comorbidity that difficult o disable respiratory rehabilitation program carrying out. * Life expectation less than 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.- Clinical: dyspnea (area of CRQ questionnaire), | 1.5 YEARS |
| Effort capacity (6minute Walking Test), | 1.5 Years |
| BODE index; | 1.5 Years |
| Economical: direct costs (programs); | 1.5 Years |
| indirect costs (exacerbations, admissions); | 1.5 Years |
| comparison of GR1 and GR2 costs; | 1.5 Years |
Countries
Spain
Outcome results
None listed