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Chronic Obstructive Pulmonary DiseaseNCT00413543

Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

A study testing early pulmonary lung rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Isala at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
early pulmonary lung rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteNetherlands
Study dates
Oct 2006to Oct 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Isala Klinieken

    Zwolle, Overijssel, 8011 JW

Other trials in Netherlands

About this study

Official title: Early Pulmonary Rehabilitation After Hospitalisation for Acute Exacerbation COPD

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.

Read the 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.

Being tested
early pulmonary lung rehabilitation
Keywords
COPD, exacerbation, pulmonary rehabilitation, exercise tolerance, exacerbations, quality of life, readmissions
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early pulmonary lung rehabilitationOther

    early pulmonary rehabilitation, 10 days after discharge

Study groups in NCT00413543
Study groupRoleWhat they receive
interventional, rehabilitationExperimental'early pulmonary lung rehabilitation'
Receives: Other: early pulmonary lung rehabilitation
controlNo intervention"standard care"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise tolerance in meters

    Measured: 2 years

Secondary outcomes (1)
  1. Exacerbations, readmissions and quality of life during follow-up

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionOct 2007
  4. Study completionOct 2007

Why it stopped: enrollment insufficient: lack of motivated patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413543
Sponsor's protocol ID
NL11494.075.06
Status last verified
Sep 2015
First submitted
18 Dec 2006
Last updated
18 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing early pulmonary lung rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Isala at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: enrollment insufficient: lack of motivated patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise tolerance in meters (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.

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