Chronic Obstructive Pulmonary DiseaseNCT02100709
The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
A study testing BiLevel Noninvasive Ventilation in people with Chronic Obstructive Pulmonary Disease, run by ResMed at 1 site in Germany.
Trial summary
This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on: the amount of daily physical activity Quality of life The 6-minute walk distance Time to exacerbation and compare it to the effect of 4 weeks of outpatients rehabilitation with… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BiLevel Noninvasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Oct 2016
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD III+IV
- Age >18 years
- Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher
Who cannot join
- Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks
- non-pulmonary Exercise impairment (amputation, severe heart disease, etc)
- any disease that precludes exercise training
- inability to understand the patient information
- substance abuse
- oxygen requirement of more than 6l O2/min during exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program
This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on:
- the amount of daily physical activity
- Quality of life
- The 6-minute walk distance
- Time to exacerbation and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BiLevel Noninvasive Ventilation
- 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.
BiLevel Noninvasive VentilationDevice
Also called NIV, BiPAP, Pressure Support Ventilation, PSV
Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance. |
| Intervention Arm | Active comparator | This arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator. Receives: Device: BiLevel Noninvasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Physical Activity
The primary outcome will be measured by daily activity using accelerometer arm bands. This will be measured at the beginning of the rehabilitation program, at the end and at a 3 month follow up.
Measured: 3 Months
Exercise Capacity
6 Minute Walking Distance will be measured every week during the exercise program.
Measured: 6 Weeks
Secondary outcomes (3)
Quality of Life
Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.
Measured: 3 Months
Dyspnoea
Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale.
Measured: 6 Weeks
Change in Physiological Parameters
Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Sample size calculation would have been overinflated; re-think study design
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.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Teschler, Prof. Dr. med., Principal investigator, Dept. Respiratory & Sleep Medicine - Ruhrlandklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100709
- Sponsor's protocol ID
- RMD_NIV_COPD_001
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2014
- Last updated
- 2 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program
- ClinicalTrials.gov ID
- NCT02100709
- Acronym / sponsor ID
- RMD_NIV_COPD_001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sample size calculation would have been overinflated; re-think study design
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Apr 2014 (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 trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on:
- the amount of daily physical activity
- Quality of life
- The 6-minute walk distance
- Time to exacerbation and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance. |
| Intervention Arm | Active comparator | Device: BiLevel Noninvasive VentilationThis arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD III+IV
- Age >18 years
- Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher
Key exclusion criteria (6 listed)
- Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks
- non-pulmonary Exercise impairment (amputation, severe heart disease, etc)
- any disease that precludes exercise training
- inability to understand the patient information
- substance abuse
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 |
|---|---|---|
| BiLevel Noninvasive VentilationAlso: NIV, BiPAP, Pressure Support Ventilation, PSVPositive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration. | Device | Intervention Arm |
Primary outcome
Daily Physical Activity
Time frame: 3 Months
The primary outcome will be measured by daily activity using accelerometer arm bands. This will be measured at the beginning of the rehabilitation program, at the end and at a 3 month follow up.
Exercise Capacity
Time frame: 6 Weeks
6 Minute Walking Distance will be measured every week during the exercise program.
3 secondary outcomes
Quality of Life
Time frame: 3 Months
Dyspnoea
Time frame: 6 Weeks
Change in Physiological Parameters
Time frame: 3 Months
Results and safety
The study was stopped early (reason given: Sample size calculation would have been overinflated; re-think study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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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.
Helmut Teschler, Prof. Dr. med. principal investigator
Dept. Respiratory & Sleep Medicine - Ruhrlandklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiLevel Noninvasive Ventilation in people with Chronic Obstructive Pulmonary Disease, run by ResMed 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 6 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 2 May 2017. 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 was stopped early (reason given: Sample size calculation would have been overinflated; re-think study design). 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?
Daily Physical Activity (time frame: 3 Months). The study lists 2 primary outcomes in all. 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 2 May 2017.