NCT06091358

Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of Bath · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-20
• Primary completion: 2024-03-29
• Completion: 2024-04-20
• First posted: 2023-10-19
• Last updated: 2023-11-30

Locations

1 site across 1 country: United Kingdom