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

Last updated: November 29, 2023
Sponsor: University of Bath
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

PrO2

Clinical Study ID

NCT06091358
MSES 22/23-013-A1
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.
  • Aged between 18 and 65

Exclusion

Exclusion Criteria:

  • Are pregnant
  • Receiving treatment following a previous cardiac event (Myocardial-infarction andNon-ST elevation MI),
  • Have a dementia diagnosis,
  • Have a high risk of falls,
  • Have an additional chronic respiratory disease diagnosis such as (Chronic obstructivepulmonary disease) COPD or CF (cystic fibrosis)
  • Are receiving respiratory muscle training
  • Are receiving steroid inhaler treatment

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: PrO2
Phase:
Study Start date:
October 20, 2023
Estimated Completion Date:
April 20, 2024

Study 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.

Connect with a study center

  • The University of Bath

    Bath, BA2 7AY
    United Kingdom

    Active - Recruiting

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