Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06091358
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-10-18
Brief Title:
Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation
Sponsor:
University of Bath
Organization:
University of Bath
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 HRMaxwill be measured Participants will be asked to cycle until they reach a 17 RPE on a ramp test of 10-15Wmin 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
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 HRMaxwill be measured Participants will be asked to cycle until they reach a 17 RPE on a ramp test of 10-15Wmin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None