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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: long-term maintenance respiratory rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT01090999

PR04/04/2007

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: Under 77 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

1

No Intervention group

Description:

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.

2

Active Comparator group

Description:

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.

Treatment:

Other: long-term maintenance respiratory rehabilitation program