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

NCT06091358 | Unknown

• 1 other identifier: MSES 22/23-013-A1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Keywords

Dyspnea; Long COVID

Outcome Measures

Primary Outcomes (1)

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

  Maximal inspiratory muscle pressure (cmH20)

  Baseline, and week 4

Secondary Outcomes (5)

• Change in Peak expiratory flow (PEF) at week 4.

  Baseline, and week 4

• Change in Ventilatory threshold (VT) at week 4.

  Baseline, and week 4

• Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).

  Baseline, and week 4

• Change in 6 minute walk test distance at week 4

  Baseline, and week 4

• Change in Forced ventilatory equivalent 1 second (FEV1) at week 4

  Baseline, and week 4

Other Outcomes (9)

• Change in Maximum heart rate during submaximal exercise test at week 4.

  Baseline, and week 4

• Change in Blood pressure at week 4

  Baseline, and week 4

• Change in Body mass index (BMI) at week 4

  Baseline, and week 4

Study Arms (2)

Control

NO INTERVENTION

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

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.

Device: PrO2

Interventions

PrO2 DEVICE

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.

Inspiratory Muscle training intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• Swansea University: collaborator

Study Sites (1)

The University of Bath

Bath, BA2 7AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Dyspnea

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Rachel Eddy

CONTACT

00000000; re415@bath.ac.uk

Dylan Thompson

CONTACT

spsdt@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomised parallel control group pilot investigation

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 19, 2023
• Study Start: October 20, 2023
• Primary Completion: March 29, 2024
• Study Completion: April 20, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)