Clinical trial NCT06091358: Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Keywords: Dyspnea
Long COVID
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: Swansea University
First posted: 2023-10-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised parallel control group pilot investigation
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Maximal inspiratory muscle pressure (MIP) at week 4.
timeFrame: Baseline, and week 4
Secondary outcomes:
measure: Change in Peak expiratory flow (PEF) at week 4.
timeFrame: Baseline, and week 4
measure: Change in Ventilatory threshold (VT) at week 4.
timeFrame: Baseline, and week 4
measure: Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).
timeFrame: Baseline, and week 4
measure: Change in 6 minute walk test distance at week 4
timeFrame: Baseline, and week 4
measure: Change in Forced ventilatory equivalent 1 second (FEV1) at week 4
timeFrame: Baseline, and week 4
Other outcomes:
measure: Change in Maximum heart rate during submaximal exercise test at week 4.
timeFrame: Baseline, and week 4
measure: Change in Blood pressure at week 4
timeFrame: Baseline, and week 4
measure: Change in Body mass index (BMI) at week 4
timeFrame: Baseline, and week 4
measure: Change in Rating of perceived exertion (RPE) across submaximal exercise and 6 minute walk at week 4
timeFrame: Baseline, and week 4
measure: Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4
timeFrame: Baseline, and week 4
measure: Change in General health questionnaire (IPAQ) in week 4
timeFrame: Baseline, and week 4
measure: Change in Pittsburgh sleep quality index (PSQI) in week 4
timeFrame: Baseline, and week 4
measure: Change in Post COVID-19 fatigue scale in week 4
timeFrame: Baseline, and week 4
measure: Change in EQ-5D-5L in week 4
timeFrame: Baseline, and week 4
Locations:
city: Bath
country: United Kingdom
facility: The University of Bath
Study officials:
References: