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Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
early pulmonary lung rehabilitation
Sponsored by
Isala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, exacerbation, pulmonary rehabilitation, exercise tolerance, exacerbations, quality of life, readmissions

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

interventional, rehabilitation

control

Arm Description

'early pulmonary lung rehabilitation'

"standard care"

Outcomes

Primary Outcome Measures

Exercise tolerance in meters

Secondary Outcome Measures

Exacerbations, readmissions and quality of life during follow-up

Full Information

First Posted
December 18, 2006
Last Updated
September 17, 2015
Sponsor
Isala
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1. Study Identification

Unique Protocol Identification Number
NCT00413543
Brief Title
Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Official Title
Early Pulmonary Rehabilitation After Hospitalisation for Acute Exacerbation COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
enrollment insufficient: lack of motivated patients
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isala

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, exacerbation, pulmonary rehabilitation, exercise tolerance, exacerbations, quality of life, readmissions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interventional, rehabilitation
Arm Type
Experimental
Arm Description
'early pulmonary lung rehabilitation'
Arm Title
control
Arm Type
No Intervention
Arm Description
"standard care"
Intervention Type
Other
Intervention Name(s)
early pulmonary lung rehabilitation
Intervention Description
early pulmonary rehabilitation, 10 days after discharge
Primary Outcome Measure Information:
Title
Exercise tolerance in meters
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Exacerbations, readmissions and quality of life during follow-up
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 40 years and < 80 years admitted to the hospital via ER COPD at least Gold II At least 10 pack years of smoking history Physical therapy is tolerated, outside pulmonary rehabilitation Exclusion Criteria: Rehabilitation program < 1 year Intolerance to prednisone Non-compliance Comorbidity limiting pulmonary rehabilitation History of asthma Prior randomisation Findings on X thorax other than fitting with COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Willem Van den Berg, Dr.
Organizational Affiliation
Isala
Official's Role
Study Director
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8011 JW
Country
Netherlands

12. IPD Sharing Statement

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Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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