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.
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.
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- 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 group | Role | What they receive |
|---|---|---|
| interventional, rehabilitation | Experimental | 'early pulmonary lung rehabilitation' Receives: Other: early pulmonary lung rehabilitation |
| control | No intervention | "standard care" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance in meters
Measured: 2 years
Secondary outcomes (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.
- First posted19 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: enrollment insufficient: lack of motivated patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan W.K. van den Berg, Isala
- Investigators
- Jan Willem Van den Berg, Dr., Study director, Isala
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pulmonary Rehabilitation After Hospitalisation for Acute Exacerbation COPD
- ClinicalTrials.gov ID
- NCT00413543
- Acronym / sponsor ID
- NL11494.075.06
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, exacerbation, pulmonary rehabilitation, exercise tolerance, exacerbations, quality of life, readmissions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment insufficient: lack of motivated patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional, rehabilitation | Experimental | Other: early pulmonary lung rehabilitation'early pulmonary lung rehabilitation' |
| control | No intervention | –"standard care" |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Rehabilitation program < 1 year
- Intolerance to prednisone
- Non-compliance
- Comorbidity limiting pulmonary rehabilitation
- History of asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early pulmonary lung rehabilitationearly pulmonary rehabilitation, 10 days after discharge | Other | interventional, rehabilitation |
Primary outcome
Exercise tolerance in meters
Time frame: 2 years
1 secondary outcome
Exacerbations, readmissions and quality of life during follow-up
Time frame: 2 years
Results and safety
The study was stopped early (reason given: enrollment insufficient: lack of motivated patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Willem Van den Berg, Dr. study director
Isala
1 site in 1 country: see every site and its status.
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.