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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
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.
The University of Bath
Bath, United Kingdom
RECRUITINGChange in Maximal inspiratory muscle pressure (MIP) at week 4.
Maximal inspiratory muscle pressure (cmH20)
Time frame: Baseline, and week 4
Change in Peak expiratory flow (PEF) at week 4.
Peak expiratory flow (PEF) (l/min)
Time frame: Baseline, and week 4
Change in Ventilatory threshold (VT) at week 4.
Ventilatory threshold (VT)
Time frame: Baseline, and week 4
Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).
BDI and TDI
Time frame: Baseline, and week 4
Change in 6 minute walk test distance at week 4
6 minute walk test difference (m)
Time frame: Baseline, and week 4
Change in Forced ventilatory equivalent 1 second (FEV1) at week 4
Forced ventilatory equivalent 1 second (FEV1) (%)
Time frame: Baseline, and week 4
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