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

NCT ID: NCT01090999

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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.

Group Type: ACTIVE_COMPARATOR

long-term maintenance respiratory rehabilitation program

Intervention Type: OTHER

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.

Interventions

long-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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Barcelona, Barcelona, Spain

Countries

Spain

References

Guell MR, Cejudo P, Ortega F, Puy MC, Rodriguez-Trigo G, Pijoan JI, Martinez-Indart L, Gorostiza A, Bdeir K, Celli B, Galdiz JB. Benefits of Long-Term Pulmonary Rehabilitation Maintenance Program in Patients with Severe Chronic Obstructive Pulmonary Disease. Three-Year Follow-up. Am J Respir Crit Care Med. 2017 Mar 1;195(5):622-629. doi: 10.1164/rccm.201603-0602OC.

Reference Type: DERIVED

PMID: 27611807 (View on PubMed)

Other Identifiers

PR04/04/2007

Identifier Type: -

Identifier Source: org_study_id