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NIV-Training in Hypercapnic COPD Patients

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ClinicalTrials.gov Identifier: NCT03803358
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
Löwenstein Medical GmbH & Co. KG
Bad Reichenhaller Forschungsanstalt
Information provided by (Responsible Party):
Klaus Kenn, Schön Klinik Berchtesgadener Land

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Other: exercise training with non-invasive ventilation Other: standard exercise training without NIV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cycle exercise with additional NIV
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.
Other: exercise training with non-invasive ventilation
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.

Active Comparator: cycle exercise without NIV
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.
Other: standard exercise training without NIV
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.




Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: Day 1 and Day 21 ]
    Change in cycle endurance time without NIV within PR


Secondary Outcome Measures :
  1. Partial pressure of transcutaneous carbon dioxide [ Time Frame: Day 1 and Day 21 ]
    Change in partial pressure of carbon dioxide levels during CET, recorded via SenTec (Switzerland, Therwill)

  2. Oxygen saturation [ Time Frame: Day 1 and Day 21 ]
    Change in Oxygen Saturation during CET, recorded via SenTec (Switzerland, Therwill)

  3. Heart rate [ Time Frame: Day 1 and Day 21 ]
    Change in Heart Rate during CET, recorded via SenTec (Switzerland, Therwill)

  4. Partial pressure of carbon dioxide [ Time Frame: Day 1 and Day 21 ]
    Change in partial pressure of carbon dioxide pre/ post CET, recovery, isotime, recorded via capillary taken blood gases

  5. Partial pressure of oxygen [ Time Frame: Day 1 and Day 21 ]
    Change in partial pressure of oxygen pre/ post CET, recovery, isotime, recorded via capillary taken blood gases

  6. Arterial blood pressure [ Time Frame: Day 1 and Day 21 ]
    Change in arterial blood pressure pre/ post CET, recovery, isotime

  7. Patients perception - Dyspnoe [ Time Frame: Day 1 and Day 21 ]
    Change in perceived dyspnoea /respiratory effort pre/ post CET, recovery, isotime recorded via Borg Scale

  8. Patients perception - leg fatigue [ Time Frame: Day 1 and Day 21 ]
    Change in perceived leg fatigue pre/ post CET, recovery, isotime recorded via Borg Scale

  9. Patients Quality of life - Chronic Respiratory Questionnaire [ Time Frame: Day 1 and Day 21 ]
    Change in Chronic Respiratory Questionnaire

  10. Patients Quality of life - Severe Respiratory Insufficiency Questionnaire [ Time Frame: Day 1 and Day 21 ]
    Change in Severe Respiratory Insufficiency Questionnaire

  11. Anxiety and Depression [ Time Frame: Day 1 and Day 21 ]
    Change in Hospital Anxiety and Depression Scale

  12. Maximal voluntary muscle contraction [ Time Frame: Day 1 and Day 21 ]
    Change in muscle contraction force (m. rectus femoris) recorded via MicroFet

  13. Patients perception to physical Training with additional NIV [ Time Frame: Day 1 and Day 21 ]
    Patients in the Intervention Group will be interviewed how they perceived the Treatment, via a questionnaire with open- and closed ended questions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803358


Contacts
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Contact: Klaus Klaus, Prof. Dr. +49 8652 93 2730 KKenn@schoen-klinik.de
Contact: Tessa Schneeberger, M.Sc. +49 8652 93 2730 TSchneeberger@schoen-klinik.de

Locations
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Germany
Schoen Klinik Berchtesgadener Land Recruiting
Schönau Am Königssee, Bayern, Germany, 83471
Contact: Klaus Kenn, Prof. Dr.    0049865293 ext 1540    KKenn@Schoen-Kliniken.de   
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
Löwenstein Medical GmbH & Co. KG
Bad Reichenhaller Forschungsanstalt
Investigators
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Principal Investigator: Klaus Kenn, Prof. Dr. Philipps University of Marburg, Department of pulmonary rehabilitation
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Responsible Party: Klaus Kenn, Prof. Dr. Klaus Kenn, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT03803358    
Other Study ID Numbers: NIV-Training
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Kenn, Schön Klinik Berchtesgadener Land:
CHRF
NIV
exercise training
Additional relevant MeSH terms:
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Hypercapnia
Signs and Symptoms, Respiratory