Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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. Identifier: NCT00413543
Recruitment Status : Terminated (enrollment insufficient: lack of motivated patients)
First Posted : December 19, 2006
Last Update Posted : September 18, 2015
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: early pulmonary lung rehabilitation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Pulmonary Rehabilitation After Hospitalisation for Acute Exacerbation COPD
Study Start Date : October 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: interventional, rehabilitation
'early pulmonary lung rehabilitation'
Other: early pulmonary lung rehabilitation
early pulmonary rehabilitation, 10 days after discharge
No Intervention: control
"standard care"

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00413543

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

Responsible Party: Jan W.K. van den Berg, pulmonologist, Isala Identifier: NCT00413543     History of Changes
Other Study ID Numbers: NL11494.075.06
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by Jan W.K. van den Berg, Isala:
pulmonary rehabilitation
exercise tolerance
quality of life

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