Long COVIDNCT06091358
Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.
A study testing PrO2 in people with Long COVID, run by University of Bath at 1 site in United Kingdom.
Trial summary
This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- PrO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.
- Aged between 18 and 65
Who cannot join
- Are pregnant
- Receiving treatment following a previous cardiac event (Myocardial-infarction and Non-ST elevation MI),
- Have a dementia diagnosis,
- Have a high risk of falls,
- Have an additional chronic respiratory disease diagnosis such as (Chronic obstructive pulmonary disease) COPD or CF (cystic fibrosis)
- Are receiving respiratory muscle training
- Are receiving steroid inhaler treatment
Trial locations and contacts
1 site in 1 country.
Dylan Thompson contact
United Kingdom1 site, 1 recruiting
- Recruiting
The University of Bath
Bath, BA2 7AY
Dylan Thompson, Phd, +44 (0) 1225 383448, spsdt@bath.ac.uk
James Betts, Phd, +44 (0) 1225 383448, jb335@bath.ac.uk
About this study
Official title: Does a 4-week Inspiratory Muscle Training Intervention (IMT) Increase Inspiratory Muscle Pressure (MIP) and Other Functional Outcomes in People With Long COVID? A Pilot Investigation
This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention.
Read the detailed description
The study design is a 4 - week parallel-arm intervention, randomised controlled trial. Participants will attend 2 testing days, baseline and follow-up 4 weeks apart.
Participants will first be screened over the phone to assess eligibility. Participants will then be randomly allocated using minimisation, into either control or intervention arm.
Baseline testing:
Participants will undergo baseline testing in the laboratory.
Participants will be measured for their anthropometrics; height and weight. Participants will complete a series of questionnaires for 15 mins.
Following 15 minutes rest, participants will then have three resting blood pressure and heart rate measurements and averaged via a sphygmomanometer and polar HR watch.
MIP will be measured using the MicroRPM care fusion 3 times and the highest value reported (10 minutes). Forced expiratory value in 1 second (FEV1) and peak expiratory flow (PEF) will be measured using Vitalograph 700 (Spirotrac 6).
Participants will undergo a 6-minute-walk-test self-paced where Rating of perceived exertion (RPE) and Borg dyspnea scale (BDS) will be assessed each minute. Then a sub-maximal exercise test using a cycle ergometer and VyntusCPX, where Ventilatory threshold (VT) and Maximal heart rate (HRMax)will be measured. Participants will be asked to cycle until they reach a 17 RPE on a ramp test of 10-15W/min (>20mins). Heart rate (HR), Rating percieved exertion (RPE) and Borg dyspnea scale BDS) measured each minute.
The intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week. Participants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day. The control group will be asked to continue as normal throughout the 4 weeks.
- Conditions
- Long COVID
- Being tested
- PrO2
- Keywords
- Dyspnea, Long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrO2Device
The intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week.
Participants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day each week.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17. Participants continue usual life between baseline and follow up testing. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device. After 4 weeks, participants will return to the Laboratory and repeat baseline testing. |
| Inspiratory Muscle training intervention | Experimental | Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17.
Participants undergo inspiratory muscle training for 4 weeks between baseline and follow up testing. They will be given a PrO2 device where the intervention will be 3 times per week for 4 weeks. Each session will be 6x6 breaths at 80% MIP. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device.
After 4 weeks, participants will return to the Laboratory and repeat baseline testing. Receives: Device: PrO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal inspiratory muscle pressure (MIP) at week 4.
Maximal inspiratory muscle pressure (cmH20)
Measured: Baseline, and week 4
Secondary outcomes (5)
Change in Peak expiratory flow (PEF) at week 4.
Peak expiratory flow (PEF) (l/min)
Measured: Baseline, and week 4
Change in Ventilatory threshold (VT) at week 4.
Ventilatory threshold (VT)
Measured: Baseline, and week 4
Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).
BDI and TDI
Measured: Baseline, and week 4
Change in 6 minute walk test distance at week 4
6 minute walk test difference (m)
Measured: Baseline, and week 4
Change in Forced ventilatory equivalent 1 second (FEV1) at week 4
Forced ventilatory equivalent 1 second (FEV1) (%)
Measured: Baseline, and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start20 Oct 2023
- Primary completion29 Mar 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised parallel control group pilot investigation
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Principal investigator, Rachel Eddy, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091358
- Sponsor's protocol ID
- MSES 22/23-013-A1
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a 4-week Inspiratory Muscle Training Intervention (IMT) Increase Inspiratory Muscle Pressure (MIP) and Other Functional Outcomes in People With Long COVID? A Pilot Investigation
- ClinicalTrials.gov ID
- NCT06091358
- Acronym / sponsor ID
- MSES 22/23-013-A1
- Conditions
- Long COVID
- Keywords
- Dyspnea, Long COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention.
Detailed description
The study design is a 4 - week parallel-arm intervention, randomised controlled trial. Participants will attend 2 testing days, baseline and follow-up 4 weeks apart.
Participants will first be screened over the phone to assess eligibility. Participants will then be randomly allocated using minimisation, into either control or intervention arm.
Baseline testing:
Participants will undergo baseline testing in the laboratory.
Participants will be measured for their anthropometrics; height and weight. Participants will complete a series of questionnaires for 15 mins.
Following 15 minutes rest, participants will then have three resting blood pressure and heart rate measurements and averaged via a sphygmomanometer and polar HR watch.
MIP will be measured using the MicroRPM care fusion 3 times and the highest value reported (10 minutes). Forced expiratory value in 1 second (FEV1) and peak expiratory flow (PEF) will be measured using Vitalograph 700 (Spirotrac 6).
Participants will undergo a 6-minute-walk-test self-paced where Rating of perceived exertion (RPE) and Borg dyspnea scale (BDS) will be assessed each minute. Then a sub-maximal exercise test using a cycle ergometer and VyntusCPX, where Ventilatory threshold (VT) and Maximal heart rate (HRMax)will be measured. Participants will be asked to cycle until they reach a 17 RPE on a ramp test of 10-15W/min (>20mins). Heart rate (HR), Rating percieved exertion (RPE) and Borg dyspnea scale BDS) measured each minute.
The intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week. Participants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day. The control group will be asked to continue as normal throughout the 4 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised parallel control group pilot investigation
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17. Participants continue usual life between baseline and follow up testing. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device. After 4 weeks, participants will return to the Laboratory and repeat baseline testing. |
| Inspiratory Muscle training intervention | Experimental | Device: PrO2Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17. Participants undergo inspiratory muscle training for 4 weeks between baseline and follow up testing. They will be given a PrO2 device where the intervention will be 3 times per week for 4 weeks. Each session will be 6x6 breaths at 80% MIP. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device. After 4 weeks, participants will return to the Laboratory and repeat baseline testing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.
- Aged between 18 and 65
Key exclusion criteria (7 listed)
- Are pregnant
- Receiving treatment following a previous cardiac event (Myocardial-infarction and Non-ST elevation MI),
- Have a dementia diagnosis,
- Have a high risk of falls,
- Have an additional chronic respiratory disease diagnosis such as (Chronic obstructive pulmonary disease) COPD or CF (cystic fibrosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrO2The intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week. Participants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day each week. | Device | Inspiratory Muscle training intervention |
Primary outcome
Change in Maximal inspiratory muscle pressure (MIP) at week 4.
Time frame: Baseline, and week 4
Maximal inspiratory muscle pressure (cmH20)
5 secondary outcomes
Change in Peak expiratory flow (PEF) at week 4.
Time frame: Baseline, and week 4
Change in Ventilatory threshold (VT) at week 4.
Time frame: Baseline, and week 4
Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).
Time frame: Baseline, and week 4
Change in 6 minute walk test distance at week 4
Time frame: Baseline, and week 4
Change in Forced ventilatory equivalent 1 second (FEV1) at week 4
Time frame: Baseline, and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Thompson contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrO2 in people with Long COVID, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Eddy (00000000, re415@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal inspiratory muscle pressure (MIP) at week 4. (time frame: Baseline, and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.