CompletedNot Applicable

Respiratory Muscles After Inspiratory Muscle Training After COVID-19

Germany18 participantsStarted 2022-10-17

Plain-language summary

It is the aim of the current (follow-up) project for the first time in post-COVID-19 patients who continue to complain of shortness of breath and for whom there is no other explanation than possibly proven diaphragmatic weakness, to determine the effects of 6 weeks of IMT/diaphragm training on diaphragm strength and shortness of breath.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 patients with survived COVID-19, persistent otherwise unexplainable dyspnoea and proven diaphragm dysfunction * Patients aged at least 18 years, who are mentally and physically able to consent and participate into the study Exclusion Criteria: * Diagnosis of another disease, which causes a permanent increase in carbon dioxide level in the blood (chronic hypercapnia) or a permanent combined lung weakness (particularly a neuromuscular disease) * Body-mass-index (BMI) \>40 * Expected absence of active participation of the patient in study-related measurements * Alcohol or drug abuse * Metal implant in the body that is not MRI compatible (NON MRI compatible pacemaker, implantable defibrillator, cervical implants, e.g. brain pacemakers etc.) * Slipped disc * Epilepsy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

Timeframe: Assessed at baseline

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

Timeframe: Assessed after 6 weeks of IMT

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

Timeframe: Assessed 6 weeks after IMT

Respiratory mouth pressures

Timeframe: Assessed at baseline

Respiratory mouth pressures

Timeframe: Assessed after 6 weeks of IMT

Respiratory mouth pressures

Timeframe: Assessed 6 weeks after IMT

Trial details

NCT IDNCT05582642

SponsorRWTH Aachen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

Timeframe: Assessed at baseline

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

Timeframe: Assessed after 6 weeks of IMT

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

Timeframe: Assessed 6 weeks after IMT

Respiratory mouth pressures

Timeframe: Assessed at baseline

Respiratory mouth pressures

Timeframe: Assessed after 6 weeks of IMT

Respiratory mouth pressures

Timeframe: Assessed 6 weeks after IMT