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

University of Bath

Status: Enrolling

Conditions: Long COVID

Treatments: Device: PrO2

Study type: Interventional

Funder types: Other

Identifiers

NCT06091358

MSES 22/23-013-A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Inspiratory Muscle training intervention

Experimental group

Description:

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.

Treatment:

Device: PrO2