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

Primary Purpose

Long COVID

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PrO2
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Long COVID focused on measuring Dyspnea, Long COVID

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Bath

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Inspiratory Muscle training intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Maximal inspiratory muscle pressure (MIP) at week 4.
Maximal inspiratory muscle pressure (cmH20)

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2023
Last Updated
October 19, 2023
Sponsor
University of Bath
Collaborators
Swansea University
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1. Study Identification

Unique Protocol Identification Number
NCT06091358
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath
Collaborators
Swansea University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID
Keywords
Dyspnea, Long COVID

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised parallel control group pilot investigation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Inspiratory Muscle training intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
PrO2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Maximal inspiratory muscle pressure (MIP) at week 4.
Description
Maximal inspiratory muscle pressure (cmH20)
Time Frame
Baseline, and week 4
Secondary Outcome Measure Information:
Title
Change in Peak expiratory flow (PEF) at week 4.
Description
Peak expiratory flow (PEF) (l/min)
Time Frame
Baseline, and week 4
Title
Change in Ventilatory threshold (VT) at week 4.
Description
Ventilatory threshold (VT)
Time Frame
Baseline, and week 4
Title
Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).
Description
BDI and TDI
Time Frame
Baseline, and week 4
Title
Change in 6 minute walk test distance at week 4
Description
6 minute walk test difference (m)
Time Frame
Baseline, and week 4
Title
Change in Forced ventilatory equivalent 1 second (FEV1) at week 4
Description
Forced ventilatory equivalent 1 second (FEV1) (%)
Time Frame
Baseline, and week 4
Other Pre-specified Outcome Measures:
Title
Change in Maximum heart rate during submaximal exercise test at week 4.
Description
Maximum heart rate during submaximal exercise (bpm)
Time Frame
Baseline, and week 4
Title
Change in Blood pressure at week 4
Description
Blood pressure (mmhg)
Time Frame
Baseline, and week 4
Title
Change in Body mass index (BMI) at week 4
Description
Body mass index (BMI) (kg/m2)
Time Frame
Baseline, and week 4
Title
Change in Rating of perceived exertion (RPE) across submaximal exercise and 6 minute walk at week 4
Description
Rating of perceived exertion (RPE) (Borg)
Time Frame
Baseline, and week 4
Title
Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4
Description
Borg dyspnea scale
Time Frame
Baseline, and week 4
Title
Change in General health questionnaire (IPAQ) in week 4
Description
General health questionnaire (IPAQ)
Time Frame
Baseline, and week 4
Title
Change in Pittsburgh sleep quality index (PSQI) in week 4
Description
Pittsburgh sleep quality index (PSQI)
Time Frame
Baseline, and week 4
Title
Change in Post COVID-19 fatigue scale in week 4
Description
Post COVID-19 fatigue scale
Time Frame
Baseline, and week 4
Title
Change in EQ-5D-5L in week 4
Description
EQ-5D-5L (European Quality of Life)
Time Frame
Baseline, and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Eddy
Phone
00000000
Email
re415@bath.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Dylan Thompson
Email
spsdt@bath.ac.uk
Facility Information:
Facility Name
The University of Bath
City
Bath
ZIP/Postal Code
BA2 7AY
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dylan Thompson, Phd
Phone
+44 (0) 1225 383448
Email
spsdt@bath.ac.uk
First Name & Middle Initial & Last Name & Degree
James Betts, Phd
Phone
+44 (0) 1225 383448
Email
jb335@bath.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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