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

NCT01090999 | Completed

• 1 other identifier: PR04/04/2007
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 1.- Clinical: dyspnea (area of CRQ questionnaire),

  1.5 YEARS

• Effort capacity (6minute Walking Test),

  1.5 Years

• BODE index;

  1.5 Years

• Economical: direct costs (programs);

  1.5 Years

• indirect costs (exacerbations, admissions);

  1.5 Years

• comparison of GR1 and GR2 costs;

  1.5 Years

Study Arms (2)

1

NO INTERVENTION

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

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.

Other: long-term maintenance respiratory rehabilitation program

Interventions

long-term maintenance respiratory rehabilitation program 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.

2

Eligibility Criteria

• Age: Up to 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Barcelona, Barcelona, 08025, Spain

Location

Related Publications (1)

• 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.

  PMID: 27611807 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 23, 2010
• Study Start: October 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

ES (1)