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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090999
First Posted: March 23, 2010
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease Other: long-term maintenance respiratory rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness.

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

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

Enrollment: 116
Study Start Date: October 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.

Active Comparator: 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 77 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090999


Locations
Spain
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01090999     History of Changes
Other Study ID Numbers: PR04/04/2007
First Submitted: March 19, 2010
First Posted: March 23, 2010
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
COPD
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases