Pulmonary Disease, Chronic ObstructiveNCT00710463
Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation
An observational study of Pulmonary Disease, Chronic Obstructive, run by Deutsche Lungenstiftung e.V. at 1 site in Germany.
Trial summary
Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation. This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- May 2003to Nov 2007
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients were recruited at a single center, the rehabilitation hospital "Klinikum Berchtesgadener Land" at Germany. Patients entering the well defined, hospital based pulmonary rehabilitation programme after Januar 1, 2005 were additionally treated with nocturnal non invasive ventilation. The results of these patients were compared with a group of patients who underwent the same rehabilitation programme in the years 2003 to 2005, when non invasive ventilation was not availabe.
Who may be able to join
- Confirmed diagnosis of COPD in stages GOLD IV
- Receiving optimized medical treatment and long term oxygen treatment, if indicated
- Patient's consent to participate in this trial
Who cannot join
- Previous treatment with NIPPV
- Unwillingness or intolerance to perform NIPPV
- Acute exacerbation of COPD at baseline or during pulmonary rehabilitation,
- Significant orthopaedic or neurologic problems that reduce mobility or cooperation with physical training
- Poor controlled coexisting psychiatric or unstable cardiac disease,
- Inability to perform a six minute walk test
- Extreme hypercapnia (pCO2 > 74 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation.
This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non invasive ventilation, compared wiht a historical control group of patients who did received the same treatment without non invasive ventilation.
Read the detailed description
Non invasive ventilation is known to allow improvements if applied during endurance training, but this is technically difficult. Nocturnal application of non invasive ventilation is known to unload the ventilatory pump, reset the control of breathing, and improve sleep quality.
The protocol also aimed to evaluate the acceptance of non invasive ventilation in patients undergoing a four week inpatient pulmonary rehabilitation programme.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)
- Keywords
- COPD, non invasive ventilation, 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.
non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)Device
Also called Resmed VPAP III ST-A, Respironics Harmony
non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics.
| Study group | Role | What they receive |
|---|---|---|
| Control group | patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated. | |
| NIV treatment group | patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated, plus newly introduced nocturnal non invasive ventilation. Receives: Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony) |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walk distance
Measured: beginning to end of rehabilitation
Secondary outcomes (1)
quality of life
Measured: beginning to end of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startMay 2003
- Primary completionSep 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsche Lungenstiftung e.V.
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Investigators
- Klaus Kenn, MD, Study director, Klinikum Berchtesgadener LandUrsula Schönheit-Kenn, ME, Principal investigator, Klinikum Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710463
- Sponsor's protocol ID
- NIV and Rehabilitation
- Status last verified
- Jul 2008
- First submitted
- 2 Jul 2008
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT00710463
- Acronym / sponsor ID
- NIV and Rehabilitation
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, non invasive ventilation, pulmonary rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Deutsche Lungenstiftung e.V.University, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- May 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 4 Jul 2008 (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.
Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation.
This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non invasive ventilation, compared wiht a historical control group of patients who did received the same treatment without non invasive ventilation.
Detailed description
Non invasive ventilation is known to allow improvements if applied during endurance training, but this is technically difficult. Nocturnal application of non invasive ventilation is known to unload the ventilatory pump, reset the control of breathing, and improve sleep quality.
The protocol also aimed to evaluate the acceptance of non invasive ventilation in patients undergoing a four week inpatient pulmonary rehabilitation programme.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated. |
| NIV treatment group | – | Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated, plus newly introduced nocturnal non invasive ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were recruited at a single center, the rehabilitation hospital "Klinikum Berchtesgadener Land" at Germany. Patients entering the well defined, hospital based pulmonary rehabilitation programme after Januar 1, 2005 were additionally treated with nocturnal non invasive ventilation. The results of these patients were compared with a group of patients who underwent the same rehabilitation programme in the years 2003 to 2005, when non invasive ventilation was not availabe.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of COPD in stages GOLD IV
- Receiving optimized medical treatment and long term oxygen treatment, if indicated
- Patient's consent to participate in this trial
Key exclusion criteria (7 listed)
- Previous treatment with NIPPV
- Unwillingness or intolerance to perform NIPPV
- Acute exacerbation of COPD at baseline or during pulmonary rehabilitation,
- Significant orthopaedic or neurologic problems that reduce mobility or cooperation with physical training
- Poor controlled coexisting psychiatric or unstable cardiac disease,
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 |
|---|---|---|
| non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)Also: Resmed VPAP III ST-A, Respironics Harmonynon invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics. | Device | NIV treatment group |
Primary outcome
six minute walk distance
Time frame: beginning to end of rehabilitation
1 secondary outcome
quality of life
Time frame: beginning to end of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
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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.
Klaus Kenn, MD study director
Klinikum Berchtesgadener Land
Ursula Schönheit-Kenn, ME principal investigator
Klinikum Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Deutsche Lungenstiftung e.V. 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 3 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: finished, as of the sponsor's last update on 4 Jul 2008. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
six minute walk distance (time frame: beginning to end of rehabilitation). 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 Jul 2008.