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

Long COVID Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091358
• Other study ID #: MSES 22/23-013-A1
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: November 2023
• Source: University of Bath
• Contact: Rachel Eddy
• Phone: 00000000
• Email: re415[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 20, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.

• Aged between 18 and 65

Exclusion Criteria:

• Are pregnant

• 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

Related Conditions & MeSH terms

• Long COVID
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The University of Bath	Bath

Sponsors (2)

Lead Sponsor	Collaborator
University of Bath	Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Maximum heart rate during submaximal exercise test at week 4.	Maximum heart rate during submaximal exercise (bpm)	Baseline, and week 4
Other	Change in Blood pressure at week 4	Blood pressure (mmhg)	Baseline, and week 4
Other	Change in Body mass index (BMI) at week 4	Body mass index (BMI) (kg/m2)	Baseline, and week 4
Other	Change in Rating of perceived exertion (RPE) across submaximal exercise and 6 minute walk at week 4	Rating of perceived exertion (RPE) (Borg)	Baseline, and week 4
Other	Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4	Borg dyspnea scale	Baseline, and week 4
Other	Change in General health questionnaire (IPAQ) in week 4	General health questionnaire (IPAQ)	Baseline, and week 4
Other	Change in Pittsburgh sleep quality index (PSQI) in week 4	Pittsburgh sleep quality index (PSQI)	Baseline, and week 4
Other	Change in Post COVID-19 fatigue scale in week 4	Post COVID-19 fatigue scale	Baseline, and week 4
Other	Change in EQ-5D-5L in week 4	EQ-5D-5L (European Quality of Life)	Baseline, and week 4
Primary	Change in Maximal inspiratory muscle pressure (MIP) at week 4.	Maximal inspiratory muscle pressure (cmH20)	Baseline, and week 4
Secondary	Change in Peak expiratory flow (PEF) at week 4.	Peak expiratory flow (PEF) (l/min)	Baseline, and week 4
Secondary	Change in Ventilatory threshold (VT) at week 4.	Ventilatory threshold (VT)	Baseline, and week 4
Secondary	Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).	BDI and TDI	Baseline, and week 4
Secondary	Change in 6 minute walk test distance at week 4	6 minute walk test difference (m)	Baseline, and week 4
Secondary	Change in Forced ventilatory equivalent 1 second (FEV1) at week 4	Forced ventilatory equivalent 1 second (FEV1) (%)	Baseline, and week 4