The use of a portable positive airway pressure device to relieve shortness of breath after exercise

ISRCTN ISRCTN11274464
DOI https://doi.org/10.1186/ISRCTN11274464
Secondary identifying numbers HRC-1510-ENGVB-SS
Submission date
22/06/2015
Registration date
06/07/2015
Last edited
05/01/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name used to refer to a number of progressive devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. Feeling short of breath can lead to inactivity and muscle deconditioning in patients with COPD. Positive airway pressure (PAP) can relieve shortness of breath and improve exercise tolerance (the amount of exercise that they are able to do). This study examines the effect of PAP delivered by a battery powered handheld device to COPD patients after exercise to relieve shortness of breath.

Who can participate?
Aged at least 18 with diagnosed COPD but able to do mild exercise.

What does the study involve?
Participants are randomly allocated into one of three groups. They are all then asked to do some mild exercise. Those in group 1 are then provided with the portable PAP device to use after the exercise to ease breathlessness. Those in group 2 are provided with what looks like a portable PAP device, but it is nonfunctional (a SHAM device) to use after the exercise. Those in group 3 are asked to perform lip breathing after exercise. The time it takes to return to the shortness of breath experienced prior to exercise for each participant is determined. We anticipate that the time after exercise to return to baseline shortness of breath using the hand held device is shorter than that while using a SHAM device and pursed-lip breathing (PLB) after exercise. As a secondary outcome, we will evaluate the distance walked during exercise.

What are the possible benefits and risks of participating?
Other than possibly gaining a better understanding of their ability to exercise and contributing to general knowledge of strategies to address shortness of breath, participants will not benefit directly from enrolling in the study. Risks of study participation include breathing and general discomfort while exercising. Lung damage from the portable positive airway pressure device is a remote possibility. Participants will be closely monitored during exercise and may request that the exercise activity be terminated. Patients with a history of lung damage from positive pressure devices are not eligible to participate.

Where is the study run from?
Pittsburgh Pulmonary Associates Ltd (USA)

When is the study starting and how long is it expected to run for?
April 2014 to October 2015

Who is funding the study?
Philips Respironics (USA)

Who is the main contact?
Mr William Hardy
bill.hardy@philips.com

Contact information

Mr William Hardy
Public

Philips Respironics
1740 Golden Mile Highway
Monroeville
PA 15146
United States of America

Phone + 724 387 4169
Email bill.hardy@philips.com

Study information

Study designProspective, interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffect of intermittent positive air pressure in relieve of shortness of breath in COPD patients after exertion.
Study objectivesTo determine whether intermittent positive airway pressure given after exercise to patients with COPD can shorten their shortness of breath recovery period
Ethics approval(s)Allendale Institutional Review Board (AIRB), 26/03/2015
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease
InterventionParticipants are asked to undergo exercise session and then use one of the following to alleviate shortness of breath:
1. Portable battery powered positive airway pressure (PAP) device
2. Portable sham positive airway pressure device
3. Pursed lip breathing
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureTime to return to baseline shortness of breath rating after exercise
Secondary outcome measuresDistance walked during exercise
Overall study start date06/04/2014
Completion date30/10/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. Age ≥ 18
2. Ability to provide consent
3. COPD diagnosis with FEV1 < 55 and > 25 of predicted value
4. Perceived Shortness of Breath via the Modified Medical Research Counsel Dyspnea questionnaire (rating of 2 or greater)
5. Able to follow directions
6. Able to tolerate mild physical activity
Key exclusion criteria1. Subjects who are acutely ill, medically complicated or who are medically unstable as determined by the investigator
2. Suffering from COPD Exacerbation at time of data collection
Date of first enrolment06/04/2015
Date of final enrolment30/10/2015

Locations

Countries of recruitment

  • United States of America

Study participating centre

Pittsburgh Pulmonary Associates, Ltd
-
United States of America

Sponsor information

Philips Respironics
Industry

1740 Golden Mile Highway
Monroeville
15146
United States of America

Website www.respironics.com
ROR logo "ROR" https://ror.org/03kw6wr76

Funders

Funder type

Industry

Philips Respironics (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planSubmitted late breaking abstract to the 2015 European Respiratory Society meeting. Upon completing recruitment of approximatlely thirty (30) participants, a peer reviewed publication is anticipated.
IPD sharing plan

Editorial Notes

13/10/2016: Internal review