NIV-Training in Hypercapnic COPD Patients

NCT03803358 | Completed

• 1 other identifier: NIV-Training
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

CHRF; NIV; exercise training

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  Change in cycle endurance time without NIV within PR

  Day 1 and Day 21

Secondary Outcomes (13)

• Partial pressure of transcutaneous carbon dioxide

  Day 1 and Day 21

• Oxygen saturation

  Day 1 and Day 21

• Heart rate

  Day 1 and Day 21

• Partial pressure of carbon dioxide

  Day 1 and Day 21

• Partial pressure of oxygen

  Day 1 and Day 21

Study Arms (2)

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.

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.

Other: standard exercise training without NIV

Interventions

exercise training with non-invasive ventilation OTHER

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.

cycle exercise with additional NIV

standard exercise training without NIV OTHER

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.

cycle exercise without NIV

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• Löwenstein Medical GmbH & Co. KG: collaborator
• Bad Reichenhaller Forschungsanstalt: collaborator

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

Location

Related Publications (1)

• 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.

  PMID: 37993279 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Klaus Kenn, Prof. Dr.

  Philipps University of Marburg, Department of pulmonary rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Klaus Kenn

Model Details: 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).

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 14, 2019
• Study Start: January 7, 2019
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)