Long COVID
Conditions
Keywords
Dyspnea, Long COVID
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 (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.
Interventions
DEVICEPrO2
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.
Sponsors
Swansea University
University of Bath
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Randomised parallel control group pilot investigation
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximal inspiratory muscle pressure (MIP) at week 4. | Baseline, and week 4 | Maximal inspiratory muscle pressure (cmH20) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced ventilatory equivalent 1 second (FEV1) at week 4 | Baseline, and week 4 | Forced ventilatory equivalent 1 second (FEV1) (%) |
| Change in Peak expiratory flow (PEF) at week 4. | Baseline, and week 4 | Peak expiratory flow (PEF) (l/min) |
| Change in Ventilatory threshold (VT) at week 4. | Baseline, and week 4 | Ventilatory threshold (VT) |
| Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI). | Baseline, and week 4 | BDI and TDI |
| Change in 6 minute walk test distance at week 4 | Baseline, and week 4 | 6 minute walk test difference (m) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in General health questionnaire (IPAQ) in week 4 | Baseline, and week 4 | General health questionnaire (IPAQ) |
| Change in Pittsburgh sleep quality index (PSQI) in week 4 | Baseline, and week 4 | Pittsburgh sleep quality index (PSQI) |
| Change in Post COVID-19 fatigue scale in week 4 | Baseline, and week 4 | Post COVID-19 fatigue scale |
| Change in EQ-5D-5L in week 4 | Baseline, and week 4 | EQ-5D-5L (European Quality of Life) |
| Change in Maximum heart rate during submaximal exercise test at week 4. | Baseline, and week 4 | Maximum heart rate during submaximal exercise (bpm) |
| Change in Blood pressure at week 4 | Baseline, and week 4 | Blood pressure (mmhg) |
| Change in Body mass index (BMI) at week 4 | Baseline, and week 4 | Body mass index (BMI) (kg/m2) |
| Change in Rating of perceived exertion (RPE) across submaximal exercise and 6 minute walk at week 4 | Baseline, and week 4 | Rating of perceived exertion (RPE) (Borg) |
| Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4 | Baseline, and week 4 | Borg dyspnea scale |
Countries
United Kingdom
Contacts
Primary ContactRachel Eddy
Backup ContactDylan Thompson
Outcome results
None listed