Respiratory Muscle Training for Shortness of Breath after COVID-19

Overseen By Sandra Morgan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Wheelchair bound, Mechanical ventilation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 12-week respiratory exercise program to determine its effectiveness in alleviating shortness of breath after COVID-19 recovery. Participants will engage in either both inspiratory (breathing in) and expiratory (breathing out) exercises or only expiratory exercises. The trial aims to enhance breathing, symptoms, walking distance, and quality of life. Individuals with a positive COVID-19 diagnosis who experience shortness of breath and can walk independently might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding and improving post-COVID-19 recovery.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. You may continue using them.

What prior data suggests that this respiratory rehabilitation program is safe for individuals with shortness of breath after COVID-19?

Research has shown that breathing exercises at home are safe for individuals with breathing difficulties after COVID-19. These exercises, which strengthen the muscles used for breathing, are generally manageable for most people, with serious side effects being rare.

For example, one study on COVID-19 recovery found that these exercises improved participants' breathing without causing harm. Participants performed these exercises at home, demonstrating their simplicity and safety for independent practice.

In summary, home-based breathing exercises appear to be a safe method to enhance breathing after COVID-19. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the home-based respiratory muscle strength training program because it offers a unique approach to managing shortness of breath after COVID-19. Unlike traditional medications or physical therapies that may require clinic visits, this program empowers patients to strengthen their respiratory muscles at home using specific breathing exercises and devices. The program includes pursed lip breathing, inspiratory muscle strength training, and expiratory muscle strength training, all designed to improve lung function over time. By targeting both inspiratory and expiratory muscles, this method has the potential to enhance breathing efficiency and overall respiratory health more comprehensively than existing treatments.

What evidence suggests that this respiratory muscle training is effective for shortness of breath after COVID-19?

Research has shown that exercises to strengthen breathing muscles can help those experiencing shortness of breath after COVID-19. Studies confirm that exercises for both inhalation and exhalation improve lung function, reduce fatigue, and ease breathlessness. Participants in these studies breathed better and walked longer distances. This trial will test a home-based respiratory muscle strength training program, including exercises like Pursed Lip Breathing, Inspiratory Muscle Strength Training (IMST), and Expiratory Muscle Strength Training (EMST). These programs have been proven to directly enhance exercise ability in individuals with ongoing symptoms after COVID-19. Importantly, these breathing exercises specifically reduce persistent shortness of breath in post-COVID patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Constance Visovsky, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who can walk on their own and think clearly. They must have had COVID-19 in the past and now suffer from persistent shortness of breath, which they rate at least a 3 out of 10 with activity or even at rest. People using oxygen or medications can join, but not those who were wheelchair-bound or needed mechanical ventilation during hospitalization.

Inclusion Criteria

I experience significant shortness of breath with activity or at rest.

May use oxygen

English-speaking

Exclusion Criteria

I use a wheelchair or need help to walk.

I was on a ventilator when I was hospitalized for COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory muscle strength training exercises

12 weeks

Measurements at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-Based Respiratory Muscle Strength Training Program

Trial Overview The study tests a home-based breathing exercise program over 12 weeks to see if it improves symptoms like shortness of breath, respiratory function, walking distance, and overall quality of life after COVID-19. Participants will do inspiratory and expiratory exercises compared to just expiratory ones.

How Is the Trial Designed?

Group I: Respiratory Muscle Strength Training Experimental Treatment 1 Intervention

Pursed Lip Breathing: Participants will perform two sets of 10 repetitions twice per day. Inspiratory Muscle Strength Training (IMST): The participant will use an IMST trainer provided by the study (Threshold Inspiratory Muscle Strength Trainer). This exercise is repeated for a 3-minute duration, followed by a rest period of 2 minutes. This cycle is repeated for 6 cycles over a 30-minute timespan. This exercise will be performed 3 times/week on alternating days. Expiratory Muscle Strength Training (EMST): The participant will use an EMST trainer (EMST 150) provided by the study. This exercise is repeated for a 3-minute duration, followed by a rest period of 2 minutes. The cycle is repeated for 6 cycles over a 30-minute timespan. This exercise will be performed 3 x/week on opposite days of the inspiratory muscle strength training.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Published Research Related to This Trial

An 8-week home-based respiratory muscle training (RMT) program significantly improved quality of life in individuals with long-term post-COVID-19 symptoms, but did not enhance exercise tolerance.

Both RMT and inspiratory muscle training (IMT) effectively increased respiratory muscle strength and lower limb muscle strength, indicating their potential benefits for physical recovery after COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based respiratory muscle training on quality of life and exercise tolerance in long-term post-COVID-19: Randomized controlled trial. Del Corral, T., Fabero-Garrido, R., Plaza-Manzano, G., et al.[2023]

A 12-week home-based pulmonary rehabilitation program significantly improved pulmonary symptoms and functional performance in 19 post-COVID-19 patients experiencing ongoing dyspnea.

The program also enhanced expiratory resistance capabilities, suggesting it could be an effective and low-cost strategy for managing post-COVID respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Pilot Pulmonary Program for Dyspneic Patients Post-COVID-19. Morgan, S., Visovsky, C., Thomas, B., et al.[2023]

A systematic review of 11 studies found that respiratory muscle strength training significantly improves dyspnea, physical capacity, and quality of life in individuals experiencing post-COVID-19 symptoms.

The training was effective both as a standalone intervention and when combined with aerobic and peripheral muscle strength training, indicating its versatility in rehabilitation for post-COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Muscle Strength Training in Patients Post-COVID-19: A Systematic Review. Morgan, SP., Visovsky, C., Thomas, B., et al.[2023]

A six-week pulmonary rehabilitation program for nine patients with post-COVID-19 syndrome significantly improved key respiratory functions, including peak expiratory flow and forced vital capacity, indicating enhanced lung function.

The program also strengthened respiratory muscles and increased the thickness of the diaphragm and quadriceps, suggesting overall improvements in muscle health and endurance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a rehabilitation protocol on pulmonary and respiratory muscle function and ultrasound evaluation of diaphragm and quadriceps femoris in patients with post-COVID-19 syndrome: a series of cases. Vieira da Costa, K., Tainá Cordeiro de Souza, I., Felix, JVDS., et al.[2023]

This study aims to evaluate the effectiveness of home-based inspiratory muscle training (IMT) in improving respiratory muscle strength, dyspnea, and quality of life in post-COVID-19 patients, using a randomized controlled trial design with a sample size determined from a pilot study.

The primary outcomes will focus on respiratory muscle strength and quality of life, with assessments occurring at three time points: before training, after three weeks of training, and at 24 weeks post-training, highlighting the potential long-term benefits of IMT for individuals suffering from long COVID syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of home-based inspiratory muscle training in patients post-covid-19: Protocol for a randomized clinical trial. Gonçalo Silva, GA., Nogueira, IDB., da Silva Chiappa, GR., et al.[2023]

In a randomized trial with 38 stroke patients, high-intensity home-based respiratory muscle training significantly improved both inspiratory and expiratory muscle strength, as well as inspiratory endurance, while also reducing feelings of breathlessness (dyspnea).

The training was conducted for 40 minutes daily over 8 weeks, and the benefits in muscle strength and reduced dyspnea were maintained even one month after the training ended, although there was no significant improvement in walking capacity or respiratory complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. Parreiras de Menezes, KK., Nascimento, LR., Ada, L., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06091280

NCT06091280 | Home-Based Respiratory Muscle Strength ... To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory muscle strength training exercises as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454434/

Advances in home-based respiratory muscle training for ... Furthermore, studies confirm that RMT significantly improves key functional outcomes—including pulmonary function, fatigue levels, and dyspnea— ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964649/

Effect of home-based pulmonary rehabilitation on exercise ... Home-based pulmonary rehabilitation (HBPR) for patients with post COVID-19 syndrome is effective and has a potential direct influence on exercise capacity.

4. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02857-4

Effectiveness of pulmonary rehabilitation programmes and/or ... The primary objective of this study was to assess the effectiveness of pulmonary rehabilitation programs and/or respiratory muscle training on ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10547738251371244

Inspiratory and Expiratory Muscle Strength Training for ... Respiratory muscle strength training has recently been reported to reduce persistent dyspnea in individuals with post-COVID-19 symptomology.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10158807/

Home-Based Pilot Pulmonary Program for Dyspneic ... The purpose of this study was to assess the efficacy of a home-based pulmonary rehabilitation program in post-COVID-19 survivors who continue to experience ...

7. withpower.com withpower.com/trial/phase-covid-19-11-2023-38178

Respiratory Muscle Training for Shortness of Breath after ... The available research shows that Respiratory Muscle Training (RMT) is effective for people experiencing shortness of breath after COVID-19. One study found ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01340-x

Effect of home-based pulmonary rehabilitation on exercise ... Home-based pulmonary rehabilitation (HBPR) for patients with post COVID-19 syndrome is effective and has a potential direct influence on exercise capacity.