Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control 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. |
|
| Experimental: Inspiratory Muscle training 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 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. |
Device: PrO2
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.
|
Outcome Measures
Primary Outcome Measures
- Change in Maximal inspiratory muscle pressure (MIP) at week 4. [Baseline, and week 4]
Maximal inspiratory muscle pressure (cmH20)
Secondary Outcome Measures
- Change in Peak expiratory flow (PEF) at week 4. [Baseline, and week 4]
Peak expiratory flow (PEF) (l/min)
- Change in Ventilatory threshold (VT) at week 4. [Baseline, and week 4]
Ventilatory threshold (VT)
- Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI). [Baseline, and week 4]
BDI and TDI
- Change in 6 minute walk test distance at week 4 [Baseline, and week 4]
6 minute walk test difference (m)
- Change in Forced ventilatory equivalent 1 second (FEV1) at week 4 [Baseline, and week 4]
Forced ventilatory equivalent 1 second (FEV1) (%)
Other Outcome Measures
- Change in Maximum heart rate during submaximal exercise test at week 4. [Baseline, and week 4]
Maximum heart rate during submaximal exercise (bpm)
- Change in Blood pressure at week 4 [Baseline, and week 4]
Blood pressure (mmhg)
- Change in Body mass index (BMI) at week 4 [Baseline, and week 4]
Body mass index (BMI) (kg/m2)
- Change in Rating of perceived exertion (RPE) across submaximal exercise and 6 minute walk at week 4 [Baseline, and week 4]
Rating of perceived exertion (RPE) (Borg)
- Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4 [Baseline, and week 4]
Borg dyspnea scale
- Change in General health questionnaire (IPAQ) in week 4 [Baseline, and week 4]
General health questionnaire (IPAQ)
- Change in Pittsburgh sleep quality index (PSQI) in week 4 [Baseline, and week 4]
Pittsburgh sleep quality index (PSQI)
- Change in Post COVID-19 fatigue scale in week 4 [Baseline, and week 4]
Post COVID-19 fatigue scale
- Change in EQ-5D-5L in week 4 [Baseline, and week 4]
EQ-5D-5L (European Quality of Life)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.
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Aged between 18 and 65
Exclusion Criteria:
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Are pregnant
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Receiving treatment following a previous cardiac event (Myocardial-infarction and Non-ST elevation MI),
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Have a dementia diagnosis,
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Have a high risk of falls,
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Have an additional chronic respiratory disease diagnosis such as (Chronic obstructive pulmonary disease) COPD or CF (cystic fibrosis)
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Are receiving respiratory muscle training
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Are receiving steroid inhaler treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Bath | Bath | United Kingdom | BA2 7AY |
Sponsors and Collaborators
- University of Bath
- Swansea University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MSES 22/23-013-A1