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Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

This study has been terminated.
(enrollment insufficient: lack of motivated patients)
Sponsor:
Information provided by:
Isala
ClinicalTrials.gov Identifier:
NCT00413543
First received: December 18, 2006
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

This is a study to evaluate the effects of early pulmonary rehabilitation within 10 days after discharge from the hospital after a COPD exacerbation on exercise tolerance, exacerbations, re-admissions and the quality of life during 6 months.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Behavioral: early pulmonary lung rehabilitation
Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Pulmonary Rehabilitation After Hospitalisation for Acute Exacerbation COPD

Resource links provided by NLM:


Further study details as provided by Isala:

Primary Outcome Measures:
  • Exercise tolerance in meters [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Exacerbations, readmissions and quality of life during follow-up [ Time Frame: 2 years ]

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
Experimental: A
Early pulmonary rehabilitation
Behavioral: early pulmonary lung rehabilitation
early pulmonary rehabilitation, 10 days after discharge
No Intervention: B
Control
Other: control
Control

Detailed Description:

Study Design:

One hundred patients with an acute exacerbation of COPD admitted to the regular pulmonology department via the emergency room will be recruited after they have given written informed consent. Inclusion criteria are an age > 40 years or ≤ 80 years, at least 10 pack years of smoking history and COPD at least GOLD II. Each form of physical therapy is accepted outside pulmonary rehabilitation. Exclusion criteria include participation in a pulmonary rehabilitation program in the preceding year, comorbidity that can limit exercise training (for example: invalidating ischaemic heart disease, RA, malignancy and lung embolus), intolerance to prednisone, history of asthma, non-compliance, findings on chest radiography other than fitting with signs of COPD and a prior randomisation. During admission patients will receive standard exacerbation COPD treatment consisting of O2, combivent inhalation, antibiotics and prednisone. Exercise capacity is measured by a 6 minute walk test performed at discharge. The COPD GOLD classification is detected with a spirometry after completion of exacerbation therapy and before randomisation and discharge.

Both measurements are repeated after completion of the pulmonary rehabilitation program at 3 months. Quality of life is evaluated by the following questionnaires at discharge: St. George respiratory questionnaire (SGRQ), SF-36-scores (short form health survey) and clinical COPD questionnaire (CCQ). Before discharge, patients are randomised with a computer minimisation program for pulmonary rehabilitation or usual care with special attendance to age (< 70 years or ≥ 70 years), sex, length of hospital stay (< 7 days or ≥ 7 days), six minute walk test distance at discharge (< 100 or ≥ 100 meters) and predicted forced expiratory volume in one second (FEV1< or ≥ FEV1). Pulmonary rehabilitation will take place within ten days after discharge and shall be given by a multidisciplinary team (pulmonologist, respiratory nurse, physical therapist, dietician and a social worker). The program will last 2 hours weekly; 1 hour exercise training and one hour education during 8 weeks. All patients are followed up after discharge at 3 and 6 months. These questionnaires will be repeated after accomplishment of the pulmonary rehabilitation program at day 90 and day 180. Readmission rate will be also evaluated in this period.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 40 years and < 80 years admitted to the hospital via ER
  2. COPD at least Gold II
  3. At least 10 pack years of smoking history
  4. Physical therapy is tolerated, outside pulmonary rehabilitation

Exclusion Criteria:

  1. Rehabilitation program < 1 year
  2. Intolerance to prednisone
  3. Non-compliance
  4. Comorbidity limiting pulmonary rehabilitation
  5. History of asthma
  6. Prior randomisation
  7. Findings on X thorax other than fitting with COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413543

Locations
Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands, 8011 JW
Sponsors and Collaborators
Isala
Investigators
Study Director: Jan Willem Van den Berg, Dr. Isala
  More Information

Publications:
1. William D. C.Man, Michael I. Polkey et al, 'Community pulmonary rehabilitation after hospitalisation for acute exacerbations of chronic obstructive pulmonary disease: randomised controlled study'; British Medical Journal 2004 November 20;329 (7476):1209 2. Milo A. Puhan, Scharplatz M. et al, 'Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality-a systematic review' ; Respiratory Research 2005; 6:54 3. Garcia-Aymerich J., Farrero E. et al,'Risk factors of readmission to hospital for a COPD exacerbation: a prospective study.'; Thorax 2003 ;58:100-5 4. Lacasse Y., Brosseau I. et al, 'Pulmonary rehabilitation for chronic obstructive pulmonary disease'; Cochrane Database Systematic Review 2002(3):CD003793 5. Griffiths T. I., Burr M.L. et al, 'Results at 1 year of outpatient multidisciplinary pulmonary rehabilitation: a randomised controlled trial' ; Lancet 2000; 355:362-8 6. Connors A.F.J., Dawson N.V. et al, 'Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risk of Treatments) 1';American Journal of Critical Care1996;154:959-967 7. Groenewegen K.H., Schols A.M.J.W. et al, 'Mortality and Mortality related factors after hospitalisation for acute exacerbation of COPD' ; Chest 2003;124:459-467 8. Seneff M.G.,Wagner D.P. et al, 'Hospital and 1-year survival of patients admitted to intensive care units with acute exacerbation of chronic obstructive pulmonary disease' ; JAMA 1995;274:1852-1857 9. Sullivan S.D., Ramsey S.D. et al, 'The economic burden of COPD'; Chest 2000;117:5S-9S 10.National Heart LBI, U.S Department of Health and Human Services NIH, Bethesda: Data Fact Sheet: Chronic Obstructive Pulmonary Disease 11.O J.B. , Rutten-van Molken M. et al , 'Resource use and risk factors in high-cost exacerbations of COPD' ; Respiriratory Medicine 2004; 98:883-891 12.Spruit M.A. , Gosselink R. et al, 'Muscle force during an acute exacerbation in hospitalised patients with COPD and its relationship with CXCL8 and IGF-I';Thorax 2003 ;58:752-756 13.Redelmeier D.A., Bayoumi A.M. et al ,'Interpreting small differences in functional status: the six minute walk test in chronic lung disease patients' ; American Journal of Respiratory Critical Care Medicine 1997 April ; 155(4):1278-82 14.Behnke M. , Jorres R.A. et al, 'Clinical benefits of a combined hospital and home-based exercise program over 18 months in patients with severe COPD' ; Monaldi Archives for Chest Disease 2003:59:44-51 15.Murphy N. , Bell C. et al , 'Extending a home from hospital care programme for COPD exacerbations to include pulmonary rehabilitation' ; Respiratory Medicine Oct 2005:1297-1302 16.Troosters T. , Gosselink R. , et al, 'Pulmonary rehabilitation improves survival in COPD patients with a recent severe acute exacerbation'; American Journal of Respiratory Critical Care 2002;165:A16 17.Bourbeau J. , Julien M. et al, 'Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management system' ; Archives of Internal Medicine 2003;163:585-591 18.Spencer S. , Jones P.W. et al, 'Time course of recovery of health status following an infective exacerbation of chronic bronchitis' ; Thorax 2003;58:589-593 19.Cilione C. ,Lorenzi C. et al , 'Predictors of change in exercise capacity after comprehensive COPD inpatient rehabilitation' ; Med Sci Monit 2002 Nov;8(11):CR740-5 20.Lau A. C. , Yam L. H. et al, 'Hospital readmission in patients with acute exacerbation of chronic obstructive pulmonary disease' ; Respiratory Medicine 2002 Oct;96(10):841 21.Tiep B. L. , 'Disease management of COPD with pulmonary rehabilitation' ; Chest 1997 Dec;112(6):1630-56 22.Kirsten D.K. , Traube C. et al, 'Exercise training improves recovery in patients with COPD after an acute exacerbation' ; Respiratory Medicine1998 Oct;92(10):1191-8 23.Vitacca M., 'Exacerbations of COPD: predictive factors, treatment and outcome' ;Monaldi Archive of Chest Disease 2001 April;56(2):137-43 24.Riario-Sforza G. G. , Incorvaia C. et al , 'Different outcomes of pulmonary rehabilitation in patients with COPD with or without exacerbations' ; Monaldi Archive of Chest Disease 2005 Sep;63(3):129-32 25.Garcia-Aymerich J. , Barreiro E. et al , 'Patients hospitalised for COPD have a high prevalence of modifiable risk factors for exacerbation' ( EFRAM study) ;European Respiratory Journal 2000;16 (1037-42) 26.Seemungal T.A.R., Donaldson G.C. et al , 'Time course and recovery of exacerbation in patients with chronic obstructive pulmonary disease' ; American Journal of Respiratory Critical Care Medicine 2000;161:1608-13

Responsible Party: Dr van den Berg, Isala klinieken
ClinicalTrials.gov Identifier: NCT00413543     History of Changes
Other Study ID Numbers: NL11494.075.06, 06.0320
Study First Received: December 18, 2006
Last Updated: January 27, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala:
COPD
exacerbation
pulmonary rehabilitation
exercise tolerance
exacerbations
quality of life
readmissions

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

ClinicalTrials.gov processed this record on November 25, 2014