Condition category
Respiratory
Date applied
15/02/2017
Date assigned
19/10/2017
Last edited
19/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a group of lung conditions that cause breathing difficulties. Breathlessness is a common symptom in COPD and can impact on a person’s exercise capacity and quality of life. A new device has been developed to improve patients’ respiratory (breathing) muscle strength and in turn reduce breathlessness. The aim of this study is to find out whether this device can manage the symptoms of breathlessness and as a result impact on exercise capacity and health-related quality of life.

Who can participate?
Patients aged 40 or above with COPD

What does the study involve?
Participants attend three hospital visits in total. The first visit involves checking their eligibility for the study and performing some breathing tests, exercise tests and questionnaires. The second visit is one week later after the participant has worn an activity monitor for 1 week. Participants are randomly allocated to use either the device or a sham (not working) device. Participants do not know which device they have until the end of the study. The device is used for 8 weeks three times per day. A daily diary of adherence is kept. On week 7 an activity monitor is worn for the final week. After 8 weeks the final visit repeats the previous tests. Those on the sham treatment are offered the working device.

What are the possible benefits and risks of participating?
Participants have the opportunity to discuss their condition with a trained healthcare professional. They receive a free device to keep once the study has ended. If allocated to the sham device they are offered the working device at the end of the study. There are no anticipated risks to taking part and the research team are happy to reimburse travel costs.

Where is the study run from?
Glenfield Hospital, University Hospitals of Leicester (UK)

When is the study starting and how long is it expected to run for?
June 2017 to December 2020

Who is funding the study?
Actegy Ltd

Who is the main contact?
Miss Enya Daynes
enya.daynes@uhl-tr.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Enya Daynes

ORCID ID

http://orcid.org/0000-0003-0127-1649

Contact details

Respiratory Biomedical Research Unit
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+44 (0)116 250 2758
enya.daynes@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

A randomised controlled trial to investigate the use of high frequency airway oscillations as training to improve dyspnoea in COPD (TIDe)

Acronym

TIDe

Study hypothesis

1. Patients training with a HFAO device for 8 weeks will have a reduction in dyspnoea and an improvement in health status compared to baseline.
2. Patients training with a HFAO device for 8 weeks will show improvements in exercise capacity, cough frequency and intensity and dyspnoea at rest and upon exertion.

Ethics approval

Leicester South Research Ethics Committee, 12/06/2017, ref: 17/EM/0156

Study design

Single-centre randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Participants are randomised by a computer generated system to one of two groups:
1. Aerosure device
2. Sham device
This will be a blinded study therefore participants will not know which device they will receive until the end of the study. The assessor will also be unaware of this.

The Aerosure Device is a high frequency oscillating device that requires maximal breathing in and out. It does not deliver any medicine but adds a resistance to breathing and oscillates the air for training benefits.

Participants will require 3 visits to hospital in total. The first will ensure eligibility and perform some breathing tests, exercise tests and questionnaires. The second visit will be one week later after they have worn an activity monitor for 1 week and will randomise them to a device. The device will be used for 8 weeks 3 times per day. A daily diary of adherence will be kept. On week 7 an activity monitor will be worn for the final week. After 8 weeks the final visit will repeat the previous measures and this will conclude the visit schedule. Those on the sham treatment will be offered the active device.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Dyspnoea is measured using the Dyspnoea domain of the Chronic Respiratory Questionnaire and the COPD assessment test at baseline and after 8 weeks of the intervention (typically 9 weeks later)

Secondary outcome measures

All outcome measures are performed at baseline and after 8 weeks of the intervention (typically 9 weeks later):
1. Respiratory muscle strength is measured via maximal mouth inspiratory muscle strength test and maximal mouth expiratory muscle strength test
2. Exercise capacity is measured via the incremental shuttle walking test and the endurance shuttle walking test
3. Health-related quality of life is measured via the Chronic Respiratory Questionnaire, COPD assessment test, Leicester Cough Questionnaire, London Activity of Daily Living Questionnaire and the Hospital Anxiety and Depression Score
4. Activity is measured using an activity monitor prior to the intervention and on week 7 of the intervention

Overall trial start date

12/06/2017

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 40 years or above
3. Confirmed diagnosed of COPD
4. MRC Score of 2 or more on the conventional 1-5 scale. (walk slower than people of the same age on the level or stops for breath when walking at own pace on the level)
5. Able to read and write in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

84

Participant exclusion criteria

1. Significant disease (other than COPD) that could cause dyspnoea or exercise limitation
2. Contraindications for exercise (unstable cardiovascular disease; hypertension etc, a full list is described by the American College of Sports Medicine and is routine deployed)
3. Inability/unwillingness to use the device
4. Contraindications to using HFAO device (including severe right heart failure with hypotension), current severe haemoptysis, ineffective cough, rib fractures, pregnancy, current or recent pneumothorax, epilepsy, current pulmonary embolism, oesophageal varices, recent thoracic, upper gastro-intestinal tract or facial surgery).
5. Previously engaged in exercised based research or pulmonary rehab in the last 6 months
6. Inability to secure informed consent
7. Those unable to communicate in full English will be excluded as the user manual is only available in English
8. Currently involved in exercise based research

Recruitment start date

27/06/2017

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital, University Hospitals of Leicester
Groby Road
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester

Sponsor details

Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Actegy Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer review journal and disseminated at conferences in 2019. The results of the study will be shared with the patient once recruitment has completed.

IPD sharing statement
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Intention to publish date

01/03/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes