Influence of the VitaBreath on Exercise Tolerance in COPD

NCT03068026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-03-05

No results posted yet for this study

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

Interventions

DEVICE

VitaBreath

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

OTHER

Pursed Lip Breathing technique

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.

Sponsors & Collaborators

  • Northumbria University

    collaborator OTHER
  • North Tyneside General Hospital

    lead OTHER_GOV

Principal Investigators

  • Ioannis Vogiatzis, Ph.D. · Northumbria University of Newcastle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2018-06-18
Completion
2018-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068026 on ClinicalTrials.gov