Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness.
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.
n/a
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