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

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.

Study Overview

• Status: Recruiting
• Conditions: Long COVID
• Intervention / Treatment: Device: PrO2

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Eddy; Phone Number: 00000000; Email: re415@bath.ac.uk
• Study Contact Backup: Name: Dylan Thompson; Email: spsdt@bath.ac.uk

Study Locations

• United Kingdom
  • Bath, United Kingdom, BA2 7AY
    • Recruiting
    • The University of Bath
    • Contact: Dylan Thompson, Phd; Phone Number: +44 (0) 1225 383448; Email: spsdt@bath.ac.uk
    • Contact: James Betts, Phd; Phone Number: +44 (0) 1225 383448; Email: jb335@bath.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximal inspiratory muscle pressure (MIP) at week 4.	Maximal inspiratory muscle pressure (cmH20)	Baseline, and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peak expiratory flow (PEF) at week 4.	Peak expiratory flow (PEF) (l/min)	Baseline, and week 4
Change in Ventilatory threshold (VT) at week 4.	Ventilatory threshold (VT)	Baseline, and week 4
Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).	BDI and TDI	Baseline, and week 4
Change in 6 minute walk test distance at week 4	6 minute walk test difference (m)	Baseline, and week 4
Change in Forced ventilatory equivalent 1 second (FEV1) at week 4	Forced ventilatory equivalent 1 second (FEV1) (%)	Baseline, and week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum heart rate during submaximal exercise test at week 4.	Maximum heart rate during submaximal exercise (bpm)	Baseline, and week 4
Change in Blood pressure at week 4	Blood pressure (mmhg)	Baseline, and week 4
Change in Body mass index (BMI) at week 4	Body mass index (BMI) (kg/m2)	Baseline, and week 4
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
Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4	Borg dyspnea scale	Baseline, and week 4
Change in General health questionnaire (IPAQ) in week 4	General health questionnaire (IPAQ)	Baseline, and week 4
Change in Post COVID-19 fatigue scale in week 4	Post COVID-19 fatigue scale	Baseline, and week 4
Change in Pittsburgh sleep quality index (PSQI) in week 4	Pittsburgh sleep quality index (PSQI)	Baseline, and week 4
Change in EQ-5D-5L in week 4	EQ-5D-5L (European Quality of Life)	Baseline, and week 4

Collaborators and Investigators

• Sponsor: University of Bath
• Collaborators: Swansea University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): March 29, 2024
• Study Completion (Estimated): April 20, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Long COVID; Dyspnea
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Respiratory Aspiration; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: MSES 22/23-013-A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No