Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease.

Study Overview
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Brief Summary
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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.

Official Title
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Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: long-term maintenance respiratory rehabilitation program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>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. The No Intervention group will undergo a standard, minimal monitoring program. | |
| Active Comparator: 2<br>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. The active comparator group will undergo an intensive maintenance program after the initial in-hospital rehabilitation program. | Other: long-term maintenance respiratory rehabilitation program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Pulmonary Rehabilitation