NIV-Training in Hypercapnic COPD Patients

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: exercise training with non-invasive ventilation; Other: standard exercise training without NIV

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Schönau Am Königssee, Bayern, Germany, 83471
      • Schoen Klinik Berchtesgadener Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise tolerance	Change in cycle endurance time without NIV within PR	Day 1 and Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial pressure of transcutaneous carbon dioxide	Change in partial pressure of carbon dioxide levels during CET, recorded via SenTec (Switzerland, Therwill)	Day 1 and Day 21
Oxygen saturation	Change in Oxygen Saturation during CET, recorded via SenTec (Switzerland, Therwill)	Day 1 and Day 21
Heart rate	Change in Heart Rate during CET, recorded via SenTec (Switzerland, Therwill)	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	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	Day 1 and Day 21
Arterial blood pressure	Change in arterial blood pressure pre/ post CET, recovery, isotime	Day 1 and Day 21
Patients perception - Dyspnoe	Change in perceived dyspnoea /respiratory effort pre/ post CET, recovery, isotime recorded via Borg Scale	Day 1 and Day 21
Patients perception - leg fatigue	Change in perceived leg fatigue pre/ post CET, recovery, isotime recorded via Borg Scale	Day 1 and Day 21
Patients Quality of life - Chronic Respiratory Questionnaire	Change in Chronic Respiratory Questionnaire	Day 1 and Day 21
Patients Quality of life - Severe Respiratory Insufficiency Questionnaire	Change in Severe Respiratory Insufficiency Questionnaire	Day 1 and Day 21
Anxiety and Depression	Change in Hospital Anxiety and Depression Scale	Day 1 and Day 21
Maximal voluntary muscle contraction	Change in muscle contraction force (m. rectus femoris) recorded via MicroFet	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	Day 1 and Day 21

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Collaborators: Löwenstein Medical GmbH & Co. KG; Bad Reichenhaller Forschungsanstalt
• Investigators: Principal Investigator: Klaus Kenn, Prof. Dr., Philipps University of Marburg, Department of pulmonary rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): July 27, 2021
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: exercise training; NIV; CHRF
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia
• Other Study ID Numbers: NIV-Training

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No