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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: long-term maintenance respiratory rehabilitation program

• Registration Number: NCT01090999
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	long-term maintenance respiratory rehabilitation program	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.

Primary Outcome Measures

Name	Time	Method
comparison of GR1 and GR2 costs;	1.5 Years
1.- Clinical: dyspnea (area of CRQ questionnaire),	1.5 YEARS
Effort capacity (6minute Walking Test),	1.5 Years
Economical: direct costs (programs);	1.5 Years
indirect costs (exacerbations, admissions);	1.5 Years
BODE index;	1.5 Years

Trial Locations

Locations (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain