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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090999
• Other study ID #: PR04/04/2007
• Status: Completed
• Phase: N/A
• First received: March 19, 2010
• Last updated: March 21, 2017
• Start date: October 2006
• Est. completion date: December 2012

Study information

• Verified date: March 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

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