Influence of the VitaBreath on Exercise Tolerance in COPD

NCT03068026 | Completed

• 1 other identifier: HRC-GRA-17030-VBREATH-SH
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

People with COPD have more air in their lungs than other people (this problem with high lung volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher lung volumes requires more effort and contributes to breathlessness. When anyone exercises, they breathe more quickly. People with COPD have narrowed airways, which makes breathing out difficult. When they breathe more quickly they may not be able to breathe out fully before they need to take the next breath in. This means that the volume of air in their lungs tends to increase further during exercise, which makes breathing even more difficult. This problem is called "dynamic hyperinflation". Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and most of the benefit gained is from exercise. Anything that helps people increase the amount of exercise they can perform should lead to further improvements. Non-invasive positive pressure ventilation is a method of supporting a person's normal breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which helps patients to breathe out more completely. The device also detects when patients start to breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a deeper breath in. Previous research studies have shown that when people with COPD use non-invasive ventilation during exercise they are able to exercise for longer and are less breathless. The purpose of this study is to assess whether a new portable non-invasive ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness during the exercise breaks more quickly (by reducing "dynamic hyperinflation", described above) and to exercise for longer overall. The VitaBreath device is small and light, weighing 0.5 kilograms (just over one pound). It is handheld and battery powered.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance (total exercise time)

  The primary outcome is exercise tolerance (total exercise time) during continuous and interval exercise.

  12 months

Secondary Outcomes (2)

• Symptoms

  12 months

• Dynamic hyperinflation

  12 months

Study Arms (2)

Continuous exercise

EXPERIMENTAL

Patients will undergo a constant load exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will be consisted of repeated 6-min exercise bouts, separated by 2-min rest periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each resting period participants will breathe normally and perform an IC maneuver to assess the magnitude of dynamic hyperinflation.

Device: VitaBreath; Other: Pursed Lip Breathing technique

Interval exercise

EXPERIMENTAL

Patients will undergo an interval exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min resting periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each rest period participants will breathe normally and perform an IC maneuver, to assess the magnitude of dynamic hyperinflation.

Device: VitaBreath; Other: Pursed Lip Breathing technique

Interventions

VitaBreath DEVICE

The VitaBreath devise will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.

Continuous exercise; Interval exercise

Pursed Lip Breathing technique OTHER

Pursed Lip Breathing technique will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.

Continuous exercise; Interval exercise

Eligibility Criteria

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

You may qualify if:

• Male or female aged 40 years or older.
• Current or previous smoking history: 10 or more pack years.
• Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
• Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline \> 0.15 L)

You may not qualify if:

• Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
• Moderate or severe COPD exacerbation within 6 weeks.
• Unstable cardiac arrhythmia.
• Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
• Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
• Uncontrolled hypertension.
• Uncontrolled hypotension (SBP\<85mmHg).
• Uncontrolled diabetes.
• Intolerance of the VitaBreath device.

Sponsors & Collaborators

• North Tyneside General Hospital: lead
• Northumbria University: collaborator

Study Sites (1)

North Tyneside General Hospital

Newcastle upon Tyne, Northumberland, NE29 8NH, United Kingdom

Location

Related Publications (10)

• Vogiatzis I, Zakynthinos S. Factors limiting exercise tolerance in chronic lung diseases. Compr Physiol. 2012 Jul;2(3):1779-817. doi: 10.1002/cphy.c110015.

  PMID: 23723024 BACKGROUND

• O'Donnell DE, Lam M, Webb KA. Spirometric correlates of improvement in exercise performance after anticholinergic therapy in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):542-9. doi: 10.1164/ajrccm.160.2.9901038.

  PMID: 10430726 BACKGROUND

• Louvaris Z, Vogiatzis I, Aliverti A, Habazettl H, Wagner H, Wagner P, Zakynthinos S. Blood flow does not redistribute from respiratory to leg muscles during exercise breathing heliox or oxygen in COPD. J Appl Physiol (1985). 2014 Aug 1;117(3):267-76. doi: 10.1152/japplphysiol.00490.2014. Epub 2014 Jun 5.

  PMID: 24903919 BACKGROUND

• O'Donnell DE, Sanii R, Younes M. Improvement in exercise endurance in patients with chronic airflow limitation using continuous positive airway pressure. Am Rev Respir Dis. 1988 Dec;138(6):1510-4. doi: 10.1164/ajrccm/138.6.1510.

  PMID: 3059897 BACKGROUND

• Keilty SE, Ponte J, Fleming TA, Moxham J. Effect of inspiratory pressure support on exercise tolerance and breathlessness in patients with severe stable chronic obstructive pulmonary disease. Thorax. 1994 Oct;49(10):990-4. doi: 10.1136/thx.49.10.990.

  PMID: 7974316 BACKGROUND

• Bianchi L, Foglio K, Pagani M, Vitacca M, Rossi A, Ambrosino N. Effects of proportional assist ventilation on exercise tolerance in COPD patients with chronic hypercapnia. Eur Respir J. 1998 Feb;11(2):422-7. doi: 10.1183/09031936.98.11020422.

  PMID: 9551748 BACKGROUND

• Wysocki M, Meshaka P, Richard JC, Similowski T. Proportional-assist ventilation compared with pressure-support ventilation during exercise in volunteers with external thoracic restriction. Crit Care Med. 2004 Feb;32(2):409-14. doi: 10.1097/01.CCM.0000108869.12426.51.

  PMID: 14758156 BACKGROUND

• van 't Hul A, Gosselink R, Hollander P, Postmus P, Kwakkel G. Acute effects of inspiratory pressure support during exercise in patients with COPD. Eur Respir J. 2004 Jan;23(1):34-40. doi: 10.1183/09031936.03.00016903.

  PMID: 14738228 BACKGROUND

• Rodrigues MK, Oliveira MF, Soares A, Treptow E, Neder JA. Additive effects of non-invasive ventilation to hyperoxia on cerebral oxygenation in COPD patients with exercise-related O2 desaturation. Clin Physiol Funct Imaging. 2013 Jul;33(4):274-81. doi: 10.1111/cpf.12024. Epub 2013 Jan 21.

  PMID: 23692616 BACKGROUND

• Ambrosino N, Cigni P. Non invasive ventilation as an additional tool for exercise training. Multidiscip Respir Med. 2015 Apr 9;10(1):14. doi: 10.1186/s40248-015-0008-1. eCollection 2015.

  PMID: 25874110 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Ioannis Vogiatzis, Ph.D.

  Northumbria University of Newcastle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized crossover trial. The two exercise modalities will be separately assessed in different groups of patients, but within each group the intervention (VitaBreath) will be compared to control (pursed-lip breathing).

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 1, 2017
• Study Start: June 6, 2017
• Primary Completion: June 18, 2018
• Study Completion: September 30, 2018
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)