COPDNCT03803358
NIV-Training in Hypercapnic COPD Patients
A study testing exercise training with non-invasive ventilation and standard exercise training without NIV in people with COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
The aim of the study is to investigate the additional effects of the use of NIV during exercise within a 3-week PR program on exercise capacity in COPD patients with chronic hypercapnic respiratory failure. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- exercise training with non-invasive ventilation and standard exercise training without NIV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2019to 27 Jul 2021
- 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
- Diagnosis of very severe COPD Gold Stage IV
- Age: 40-80 years
- PaCO2 >50mmHg (at rest, during sleep or exercise)
- Implemented nocturnal non-invasive ventilation therapy
Who cannot join
- Concomitant cardiovascular, orthopaedic or neurological conditions that are likely to be the primary impairment to exercise performance
- Other significant pulmonary disease which could affect exercise or NIV (e.g. asthma)
- BMI > 35 kg/m2
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471
About this study
Official title: The Effects of Non-invasive Ventilation During Cycle Exercise Within a 3-week Pulmonary Rehabilitation Program in COPD Patients With Chronic Hypercapnic Respiratory Failure - a Randomized Controlled Trial
The aim of the study is to investigate the additional effects of the use of NIV during exercise within a 3-week PR program on exercise capacity in COPD patients with chronic hypercapnic respiratory failure.
Read the detailed description
Scientific Background/ Rationale:
Quality of life and exercise tolerance are commonly reduced in people with chronic obstructive pulmonary disease (COPD), especially in people with chronic hypercapnic respiratory failure (CHRF). Endurance exercise training as part of a pulmonary rehabilitation (PR) programme is an important treatment for people with COPD and has been shown to improve quality of life, exercise tolerance and physical activity. However, individuals with CHRF may have difficulties performing endurance exercise at an adequate training intensity to achieve the desired physiological changes.
Non-invasive ventilation (NIV) is a method of providing breathing support using a ventilator and is usually delivered via a full face mask. A recent study showed that during a single exercise session in people with CHRF, NIV dramatically improves exercise tolerance and reduces breathlessness. Consequently, NIV used over a complete exercise training program may allow people with COPD and CHRF to exercise at a higher intensity to achieve greater improvement in exercise tolerance, quality of life and physical activity. So far this has only been tested in a small number of studies with small numbers of participants, and none with CHRF. It is currently not known from literature whether the demonstrated benefits of NIV during exercise training are clinically worthwhile or cost-effective.
Aims The aim of the study is to investigate the additional effects of the use of NIV during exercise within a 3-week PR program on exercise capacity in COPD patients with chronic hypercapnic respiratory failure.
Hypothesis It is assumed that a 3-week exercise training program with additional NIV, using titrated pressures, reduces the work of breathing. With this, it is theorized, COPD patients with CHRF are able to train for a longer duration and/ or with higher training intensities over the course of the training program and may achieve better PR outcomes.
Primary Hypothesis:
H.0: COPD-Patients with CHRF have the same increase in exercise capacity (endurance cycle time) when training with additional NIV as without NIV, during a 3-week PR program.
H.1: COPD-Patients with CHRF have a superior increase in exercise capacity (endurance cycle time) when training with additional NIV as without NIV, during a 3-week PR program.
Main Objective To determine if NIV during exercise is a useful tool for increasing exercise tolerance in hypercapnic patients, exercise tolerance (cycle endurance time) will be measured without NIV at PR admission/ discharge
Materials and Method A total of 26 COPD patient (age: 40-80 years) in GOLD Stages IV diagnosed with CHRF, already treated with nocturnal NIV and referred for a comprehensive PR program will be recruited and randomized into two groups: 1) exercise with NIV during exercise (nocturnal NIV will continue) and 2) control group - exercise without NIV during exercise (nocturnal NIV will continue).
Initially, patients will perform a maximum cardiopulmonary test to determine the Peak Work Rate (WRpeak). On a separate day, patients will perform a cycle endurance test (CET) at 75%WRpeak without NIV using oxygen as prescribed, if needed. TcPCO2, heart rate and SpO2 via SenTec will be measured continuously during CET. In addition to the continuously recorded data, dyspnoea/ respiratory effort/ leg-fatigue (10-point Borg scale), capillary blood gases and the arterial blood pressure will be taken at the beginning/ end/ recovery/ isotime of the CET.
- Conditions
- COPD
- Being tested
- exercise training with non-invasive ventilation, standard exercise training without NIV
- Keywords
- CHRF, NIV, exercise training
- 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.
exercise training with non-invasive ventilationOther
In the intervention group (exercise training with non-invasive ventilation) exercise NIV pressures will be optimally adjusted to each individual patient to decrease TcPCO2 values. An IPAP of at least 15 cmH20 will be used to provide sufficient pressure to relief patients breathing muscles. Nocturnal NIV will be continued.
standard exercise training without NIVOther
In the control Group (standard exercise training without NIV ), patients will be execute cycle exercise without additional NIV (usual care). Nocturnal NIV will be continued.
| Study group | Role | What they receive |
|---|---|---|
| cycle exercise with additional NIV | Experimental | In the intervention group (exercise training with non-invasive ventilation) exercise NIV pressures will be optimally adjusted to each individual patient to decrease TcPCO2 values. An IPAP of at least 15 cmH20 will be used to provide sufficient pressure to relief patients breathing muscles. Nocturnal NIV will be continued. Receives: Other: exercise training with non-invasive ventilation |
| cycle exercise without NIV | Active comparator | In the control Group (standard exercise training without NIV ), patients will be execute cycle exercise without additional NIV (usual care). Nocturnal NIV will be continued. Receives: Other: standard exercise training without NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
Change in cycle endurance time without NIV within PR
Measured: Day 1 and Day 21
Secondary outcomes (13)
Partial pressure of transcutaneous carbon dioxide
Change in partial pressure of carbon dioxide levels during CET, recorded via SenTec (Switzerland, Therwill)
Measured: Day 1 and Day 21
Oxygen saturation
Change in Oxygen Saturation during CET, recorded via SenTec (Switzerland, Therwill)
Measured: Day 1 and Day 21
Heart rate
Change in Heart Rate during CET, recorded via SenTec (Switzerland, Therwill)
Measured: Day 1 and Day 21
Partial pressure of carbon dioxide
Change in partial pressure of carbon dioxide pre/ post CET, recovery, isotime, recorded via capillary taken blood gases
Measured: Day 1 and Day 21
Partial pressure of oxygen
Change in partial pressure of oxygen pre/ post CET, recovery, isotime, recorded via capillary taken blood gases
Measured: Day 1 and Day 21
Arterial blood pressure
Change in arterial blood pressure pre/ post CET, recovery, isotime
Measured: Day 1 and Day 21
Patients perception - Dyspnoe
Change in perceived dyspnoea /respiratory effort pre/ post CET, recovery, isotime recorded via Borg Scale
Measured: Day 1 and Day 21
Patients perception - leg fatigue
Change in perceived leg fatigue pre/ post CET, recovery, isotime recorded via Borg Scale
Measured: Day 1 and Day 21
Patients Quality of life - Chronic Respiratory Questionnaire
Change in Chronic Respiratory Questionnaire
Measured: Day 1 and Day 21
Patients Quality of life - Severe Respiratory Insufficiency Questionnaire
Change in Severe Respiratory Insufficiency Questionnaire
Measured: Day 1 and Day 21
Anxiety and Depression
Change in Hospital Anxiety and Depression Scale
Measured: Day 1 and Day 21
Maximal voluntary muscle contraction
Change in muscle contraction force (m. rectus femoris) recorded via MicroFet
Measured: Day 1 and Day 21
Patients perception to physical Training with additional NIV
Patients in the Intervention Group will be interviewed how they perceived the Treatment, via a questionnaire with open- and closed ended questions
Measured: Day 1 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start7 Jan 2019
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Model description
- A total of 26 COPD patients in GOLD Stages IV diagnosed with CHRF, already treated with nocturnal NIV and referred for a comprehensive PR program will be recruited and randomized into two groups: 1) exercise with NIV during exercise (nocturnal NIV will continue) and 2) control group - exercise without NIV during exercise (nocturnal NIV will continue).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Löwenstein Medical GmbH & Co. KG, Bad Reichenhaller Forschungsanstalt
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Prof. Dr., Principal investigator, Philipps University of Marburg, Department of pulmonary rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803358
- Sponsor's protocol ID
- NIV-Training
- Status last verified
- Jul 2021
- First submitted
- 7 Jan 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneeberger T, Dennis CJ, Jarosch I, Leitl D, Stegemann A, Gloeckl R, Hitzl W, Leidinger M, Schoenheit-Kenn U, Criee CP, Koczulla AR, Kenn K. High-intensity non-invasive ventilation during exercise-training versus without in people with very severe COPD and chronic hypercapnic respiratory failure: a randomised controlled trial. BMJ Open Respir Res. 2023 Nov 22;10(1):e001913. doi: 10.1136/bmjresp-2023-001913.
PubMed 37993279
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Non-invasive Ventilation During Cycle Exercise Within a 3-week Pulmonary Rehabilitation Program in COPD Patients With Chronic Hypercapnic Respiratory Failure - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03803358
- Acronym / sponsor ID
- NIV-Training
- Conditions
- COPD
- Keywords
- CHRF, NIV, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Löwenstein Medical GmbH & Co. KG, Bad Reichenhaller Forschungsanstalt
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 14 Jan 2019 (actual)
- 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 investigate the additional effects of the use of NIV during exercise within a 3-week PR program on exercise capacity in COPD patients with chronic hypercapnic respiratory failure.
Detailed description
Scientific Background/ Rationale:
Quality of life and exercise tolerance are commonly reduced in people with chronic obstructive pulmonary disease (COPD), especially in people with chronic hypercapnic respiratory failure (CHRF). Endurance exercise training as part of a pulmonary rehabilitation (PR) programme is an important treatment for people with COPD and has been shown to improve quality of life, exercise tolerance and physical activity. However, individuals with CHRF may have difficulties performing endurance exercise at an adequate training intensity to achieve the desired physiological changes.
Non-invasive ventilation (NIV) is a method of providing breathing support using a ventilator and is usually delivered via a full face mask. A recent study showed that during a single exercise session in people with CHRF, NIV dramatically improves exercise tolerance and reduces breathlessness. Consequently, NIV used over a complete exercise training program may allow people with COPD and CHRF to exercise at a higher intensity to achieve greater improvement in exercise tolerance, quality of life and physical activity. So far this has only been tested in a small number of studies with small numbers of participants, and none with CHRF. It is currently not known from literature whether the demonstrated benefits of NIV during exercise training are clinically worthwhile or cost-effective.
Aims The aim of the study is to investigate the additional effects of the use of NIV during exercise within a 3-week PR program on exercise capacity in COPD patients with chronic hypercapnic respiratory failure.
Hypothesis It is assumed that a 3-week exercise training program with additional NIV, using titrated pressures, reduces the work of breathing. With this, it is theorized, COPD patients with CHRF are able to train for a longer duration and/ or with higher training intensities over the course of the training program and may achieve better PR outcomes.
Primary Hypothesis:
H.0: COPD-Patients with CHRF have the same increase in exercise capacity (endurance cycle time) when training with additional NIV as without NIV, during a 3-week PR program.
H.1: COPD-Patients with CHRF have a superior increase in exercise capacity (endurance cycle time) when training with additional NIV as without NIV, during a 3-week PR program.
Main Objective To determine if NIV during exercise is a useful tool for increasing exercise tolerance in hypercapnic patients, exercise tolerance (cycle endurance time) will be measured without NIV at PR admission/ discharge
Materials and Method A total of 26 COPD patient (age: 40-80 years) in GOLD Stages IV diagnosed with CHRF, already treated with nocturnal NIV and referred for a comprehensive PR program will be recruited and randomized into two groups: 1) exercise with NIV during exercise (nocturnal NIV will continue) and 2) control group - exercise without NIV during exercise (nocturnal NIV will continue).
Initially, patients will perform a maximum cardiopulmonary test to determine the Peak Work Rate (WRpeak). On a separate day, patients will perform a cycle endurance test (CET) at 75%WRpeak without NIV using oxygen as prescribed, if needed. TcPCO2, heart rate and SpO2 via SenTec will be measured continuously during CET. In addition to the continuously recorded data, dyspnoea/ respiratory effort/ leg-fatigue (10-point Borg scale), capillary blood gases and the arterial blood pressure will be taken at the beginning/ end/ recovery/ isotime of the CET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 26 COPD patients in GOLD Stages IV diagnosed with CHRF, already treated with nocturnal NIV and referred for a comprehensive PR program will be recruited and randomized into two groups: 1) exercise with NIV during exercise (nocturnal NIV will continue) and 2) control group - exercise without NIV during exercise (nocturnal NIV will continue).
| Arm | Type | Receives |
|---|---|---|
| cycle exercise with additional NIV | Experimental | Other: exercise training with non-invasive ventilationIn the intervention group (exercise training with non-invasive ventilation) exercise NIV pressures will be optimally adjusted to each individual patient to decrease TcPCO2 values. An IPAP of at least 15 cmH20 will be used to provide sufficient pressure to relief patients breathing muscles. Nocturnal NIV will be continued. |
| cycle exercise without NIV | Active comparator | Other: standard exercise training without NIVIn the control Group (standard exercise training without NIV ), patients will be execute cycle exercise without additional NIV (usual care). Nocturnal NIV will be continued. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of very severe COPD Gold Stage IV
- Age: 40-80 years
- PaCO2 >50mmHg (at rest, during sleep or exercise)
- Implemented nocturnal non-invasive ventilation therapy
Key exclusion criteria (4 listed)
- Concomitant cardiovascular, orthopaedic or neurological conditions that are likely to be the primary impairment to exercise performance
- Other significant pulmonary disease which could affect exercise or NIV (e.g. asthma)
- BMI > 35 kg/m2
- Inability to give informed consent
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 |
|---|---|---|
| exercise training with non-invasive ventilationIn the intervention group (exercise training with non-invasive ventilation) exercise NIV pressures will be optimally adjusted to each individual patient to decrease TcPCO2 values. An IPAP of at least 15 cmH20 will be used to provide sufficient pressure to relief patients breathing muscles. Nocturnal NIV will be continued. | Other | cycle exercise with additional NIV |
| standard exercise training without NIVIn the control Group (standard exercise training without NIV ), patients will be execute cycle exercise without additional NIV (usual care). Nocturnal NIV will be continued. | Other | cycle exercise without NIV |
Primary outcome
Exercise tolerance
Time frame: Day 1 and Day 21
Change in cycle endurance time without NIV within PR
13 secondary outcomes
Partial pressure of transcutaneous carbon dioxide
Time frame: Day 1 and Day 21
Oxygen saturation
Time frame: Day 1 and Day 21
Heart rate
Time frame: Day 1 and Day 21
Partial pressure of carbon dioxide
Time frame: Day 1 and Day 21
Partial pressure of oxygen
Time frame: Day 1 and Day 21
Arterial blood pressure
Time frame: Day 1 and Day 21
Patients perception - Dyspnoe
Time frame: Day 1 and Day 21
Patients perception - leg fatigue
Time frame: Day 1 and Day 21
Patients Quality of life - Chronic Respiratory Questionnaire
Time frame: Day 1 and Day 21
Patients Quality of life - Severe Respiratory Insufficiency Questionnaire
Time frame: Day 1 and Day 21
Anxiety and Depression
Time frame: Day 1 and Day 21
Maximal voluntary muscle contraction
Time frame: Day 1 and Day 21
Patients perception to physical Training with additional NIV
Time frame: Day 1 and Day 21
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 28 Jul 2021.
- Derived from this study: PubMed 37993279Schneeberger T, Dennis CJ, Jarosch I, Leitl D, Stegemann A, Gloeckl R, Hitzl W, Leidinger M, Schoenheit-Kenn U, Criee CP, Koczulla AR, Kenn K. High-intensity non-invasive ventilation during exercise-training versus without in people with very severe COPD and chronic hypercapnic respiratory failure: a randomised controlled trial. BMJ Open Respir Res. 2023 Nov 22;10(1):e001913. doi: 10.1136/bmjresp-2023-001913.
- Individual participant dataSharing planned: No
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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, Prof. Dr. principal investigator
Philipps University of Marburg, Department of pulmonary rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training with non-invasive ventilation and standard exercise training without NIV in people with COPD, 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 4 inclusion and 4 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 28 Jul 2021. 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?
Exercise tolerance (time frame: Day 1 and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803358, which also lists 1 linked publication.
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 28 Jul 2021.