Clinical trial NCT01090999: Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease.
Official title: Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Pulmonary Rehabilitation
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 116
Sex: ALL
Maximum age (years): 77
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 1.- Clinical: dyspnea (area of CRQ questionnaire),
timeFrame: 1.5 YEARS
measure: Effort capacity (6minute Walking Test),
timeFrame: 1.5 Years
measure: BODE index;
timeFrame: 1.5 Years
measure: Economical: direct costs (programs);
timeFrame: 1.5 Years
measure: indirect costs (exacerbations, admissions);
timeFrame: 1.5 Years
measure: comparison of GR1 and GR2 costs;
timeFrame: 1.5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: 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.