Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Early Pulmonary Rehabilitation After Hospitalisation for Acute Exacerbation COPD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00413543
• Other study ID #: NL11494.075.06
• Status: Terminated
• Phase: N/A
• First received: December 18, 2006
• Last updated: September 17, 2015
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: September 2015
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• early pulmonary lung rehabilitation
early pulmonary rehabilitation, 10 days after discharge

Locations

Country	Name	City	State
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise tolerance in meters		2 years	No
Secondary	Exacerbations, readmissions and quality of life during follow-up		2 years	No