Chronic Obstructive Pulmonary DiseaseNCT01384981
Effects of Non-invasive Ventilation on Rehabilitation Outcome in COPD-patients
A study testing pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Sep 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of COPD in stages GOLD III/ IV
- receiving optimized medical treatment and long term oxygen therapy if needed
- patients consent to participate in this trial
- no treatment with NIV in the last 4 weeks
- treatment with NIV in the last 4 weeks due to an acute exacerbation
Who cannot join
- treatment with NIV in the last 4 weeks (except due to an acute exacerbation)
- Intolerance to perform NIV
- Acute exacerbation at baseline or during PR
- Hypercapnia > pCO2 55mmHg
- Inability to perform a 6 minute walking test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV
The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- pulmonary rehabilitation
- Keywords
- chronic obstructive pulmonary rehabilitation, COPD, non invasive ventilation, NIV, exercise capacity, pulmonary rehabilitation
- 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.
pulmonary rehabilitationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pulmonary rehabilitation with NIV | Active comparator | Patients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program. Receives: Procedure: pulmonary rehabilitation |
| pulmonary rehabilitation without NIV | Sham comparator | Patients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program. Receives: Procedure: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 6 minute walking distance
change in 6 minute walking distance from baseline to day 25
Measured: day 1 and 25
Secondary outcomes (2)
change in quality of life (chronic respiratory questionnaire, CRQ)
change in CRQ-Score from baseline to day 25
Measured: day 1 and 25
change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)
change in SGRQ-Score from baseline to day 25
Measured: day 1 and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: major problems in recruiting patients due to very strict inclusion criteria
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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384981
- Sponsor's protocol ID
- BGL NIV
- Status last verified
- Sep 2015
- First submitted
- 27 Jun 2011
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV
- ClinicalTrials.gov ID
- NCT01384981
- Acronym / sponsor ID
- BGL NIV
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary rehabilitation, COPD, non invasive ventilation, NIV, exercise capacity, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: major problems in recruiting patients due to very strict inclusion criteria
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Jun 2011 (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.
The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmonary rehabilitation with NIV | Active comparator | Procedure: pulmonary rehabilitationPatients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program. |
| pulmonary rehabilitation without NIV | Sham comparator | Procedure: pulmonary rehabilitationPatients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- confirmed diagnosis of COPD in stages GOLD III/ IV
- receiving optimized medical treatment and long term oxygen therapy if needed
- patients consent to participate in this trial
- no treatment with NIV in the last 4 weeks
- treatment with NIV in the last 4 weeks due to an acute exacerbation
Key exclusion criteria (5 listed)
- treatment with NIV in the last 4 weeks (except due to an acute exacerbation)
- Intolerance to perform NIV
- Acute exacerbation at baseline or during PR
- Hypercapnia > pCO2 55mmHg
- Inability to perform a 6 minute walking test
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 |
|---|---|---|
| pulmonary rehabilitation | Procedure or surgery | pulmonary rehabilitation with NIV, pulmonary rehabilitation without NIV |
Primary outcome
change in 6 minute walking distance
Time frame: day 1 and 25
change in 6 minute walking distance from baseline to day 25
2 secondary outcomes
change in quality of life (chronic respiratory questionnaire, CRQ)
Time frame: day 1 and 25
change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)
Time frame: day 1 and 25
Results and safety
The study was stopped early (reason given: major problems in recruiting patients due to very strict inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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 5 inclusion and 5 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 4 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 Germany. 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. Some participants in this study may receive a placebo. 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: major problems in recruiting patients due to very strict inclusion criteria). 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?
change in 6 minute walking distance (time frame: day 1 and 25). 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 4 Sep 2015.