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| Name | Class |
|---|---|
| Swansea University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrO2 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximal inspiratory muscle pressure (MIP) at week 4. | Maximal inspiratory muscle pressure (cmH20) | Baseline, and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak expiratory flow (PEF) at week 4. | Peak expiratory flow (PEF) (l/min) | Baseline, and week 4 |
| Change in Ventilatory threshold (VT) at week 4. | Ventilatory threshold (VT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximum heart rate during submaximal exercise test at week 4. | Maximum heart rate during submaximal exercise (bpm) | Baseline, and week 4 |
| Change in Blood pressure at week 4 | Blood pressure (mmhg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Eddy | Contact | 00000000 | re415@bath.ac.uk | |
| Dylan Thompson | Contact | spsdt@bath.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Bath | Recruiting | Bath | BA2 7AY | United Kingdom |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Randomised parallel control group pilot investigation
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|
| Baseline, and week 4 |
| Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI). | BDI and TDI | Baseline, and week 4 |
| Change in 6 minute walk test distance at week 4 | 6 minute walk test difference (m) | Baseline, and week 4 |
| Change in Forced ventilatory equivalent 1 second (FEV1) at week 4 | Forced ventilatory equivalent 1 second (FEV1) (%) | Baseline, and week 4 |
| Baseline, and week 4 |
| Change in Body mass index (BMI) at week 4 | Body mass index (BMI) (kg/m2) | Baseline, and week 4 |
| Change in Rating of perceived exertion (RPE) across submaximal exercise and 6 minute walk at week 4 | Rating of perceived exertion (RPE) (Borg) | Baseline, and week 4 |
| Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4 | Borg dyspnea scale | Baseline, and week 4 |
| Change in General health questionnaire (IPAQ) in week 4 | General health questionnaire (IPAQ) | Baseline, and week 4 |
| Change in Pittsburgh sleep quality index (PSQI) in week 4 | Pittsburgh sleep quality index (PSQI) | Baseline, and week 4 |
| Change in Post COVID-19 fatigue scale in week 4 | Post COVID-19 fatigue scale | Baseline, and week 4 |
| Change in EQ-5D-5L in week 4 | EQ-5D-5L (European Quality of Life) | Baseline, and week 4 |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |