Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.
NCT ID: NCT06091358
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2023-10-20
2024-04-20
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 65
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Swansea University
OTHER
University of Bath
OTHER
Responsible Party
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Rachel Eddy
Principle Investigator
Locations
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The University of Bath
Bath, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dylan Thompson, Phd
Role: primary
James Betts, Phd
Role: backup
Other Identifiers
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MSES 22/23-013-A1
Identifier Type: -
Identifier Source: org_study_id