Training to improve dyspnoea
| ISRCTN | ISRCTN45695543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45695543 |
| IRAS number | 220947 |
| Secondary identifying numbers | IRAS 220947 |
- Submission date
- 15/02/2017
- Registration date
- 19/10/2017
- Last edited
- 12/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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.
This study also includes two sub-studies. One explores the benefits of pulmonary rehabilitation for patients with lung disease (named ExPORt) and one explores the rehabilitation needs of patients that had an admission following Coronavirus (CORe).
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 September 2021
Who is funding the study?
Actegy Ltd
Who is the main contact?
Miss Enya Daynes
enya.daynes@uhl-tr.nhs.uk
Contact information
Public
Respiratory Biomedical Research Unit
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0003-0127-1649 |
|---|---|
| Phone | +44 (0)116 250 2758 |
| enya.daynes@uhl-tr.nhs.uk |
Study information
| Study design | Single-centre randomised control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN45695543_PIS_FINAL_V1_MAIN_V3_clean.doc |
| Scientific title | A randomised controlled trial to investigate the use of high frequency airway oscillations as training to improve dyspnoea in COPD (TIDe) |
| Study 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(s) | Leicester South Research Ethics Committee, 12/06/2017, ref: 17/EM/0156 |
| Condition | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Current interventions as of 23/05/2020: For the main TIDe study 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 resistance to breathing and oscillates the air for training benefits. For the sub-studies ExPORt and CORe the interventions will be rehabilitation, which includes exercise and education. Participants will require 3 visits to the 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. Previous interventions: 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Aerosure device |
| Primary outcome measure | 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 | Current secondary outcome measures as of 13/02/2019: 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 5. Lung Clearance Index measured via a Multiple Breath Washout. Previous 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 study start date | 12/06/2017 |
| Overall study end date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 105 |
| Total final enrolment | 104 |
| 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 For the sub studies ExPORt and CORe (added 23/05/2020): 1. Participant is willing and able to give informed consent for participation in the study 2. Referred to the study through a clinical service (pulmonary rehabilitation or admission with COVID-19) |
| 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
- England
- United Kingdom
Study participating centre
Leicester
LE3 9QP
United Kingdom
Sponsor information
Hospital/treatment centre
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
"ROR" |
https://ror.org/02fha3693 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high impact peer review journal and disseminated at conferences in 2020 (updated 05/03/2020, previously: 2019). The results of the study will be shared with the patient once recruitment has completed. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1 | 19/10/2017 | No | Yes | |
| Protocol article | protocol | 29/07/2019 | 02/08/2019 | Yes | No |
| Participant information sheet | 23/05/2020 | 23/05/2020 | No | Yes | |
| Participant information sheet | 23/05/2020 | 23/05/2020 | No | Yes | |
| Results article | 27/10/2021 | 13/12/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Cohort sub study of early experiences and feasibility | 06/05/2021 | 12/02/2025 | Yes | No |
| Other publications | Exploratory qualitative analysis, a satisfaction survey and focus group | 13/06/2024 | 12/02/2025 | Yes | No |
| Other publications | Substudy under same ethics looking at changes in fatigue symptoms during the rehabilitation programme | 22/07/2025 | 12/02/2025 | Yes | No |
Additional files
- ISRCTN45695543_PIS_FINAL_V1_MAIN_V3_clean.doc
- Uploaded 19/10/2017
- ISRCTN45695543_PIS_ExPORt_23May20.pdf
- Uploaded 23/05/2020
- ISRCTN45695543_PIS_CORE_23May20.pdf
- Uploaded 23/05/2020
Editorial Notes
12/02/2025: Publication reference added.
13/12/2021: Publication reference added.
13/01/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2020 to 30/09/2021.
2. The intention to publish date was changed from 01/09/2020 to 01/06/2021.
3. Total final enrolment added.
23/05/2020: The following changes have been made:
1. The patient information sheets for both sub-studies have been uploaded as additional files.
2. The interventions have been updated.
3. The participant inclusion criteria have been updated.
4. The plain English summary has been updated to reflect the changes above.
5. The IRAS number has been added.
05/03/2020: The following changes were made to the trial record:
1. The publication and dissemination plan was updated.
2. The intention to publish date was changed from 01/09/2019 to 01/09/2020.
02/08/2019: Publication reference added.
13/02/2019: The following changes were made:
1. The participant inclusion criteria: Target number of participants and total target enrolment was changed from 84 to 105.
2. The intention to publish date was changed from 01/03/2019 to 01/09/2019.
3. The secondary outcome measures were changed.
