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

25 Participants Needed

Trial Summary

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 data supports the idea that Respiratory Muscle Training for Shortness of Breath after COVID-19 is an effective treatment?

The available research shows that Respiratory Muscle Training (RMT) is effective for people experiencing shortness of breath after COVID-19. One study found that a home-based RMT program improved quality of life and exercise tolerance in individuals with long-term post-COVID-19 symptoms. Another study showed significant improvements in breathing symptoms and physical performance after a 12-week home-based program. A systematic review found that RMT improved breathing, physical capacity, and quality of life in most studies. These results suggest that RMT can be a helpful and affordable option for those dealing with ongoing breathing issues after COVID-19. ^{1 2 3 4 5}

What safety data exists for respiratory muscle training for post-COVID-19 dyspnea?

The studies reviewed indicate that respiratory muscle training, including home-based programs, is generally effective in improving pulmonary measures, dyspnea, physical capacity, and quality of life in post-COVID-19 patients. While the focus is on efficacy, the consistent improvements across multiple studies suggest a favorable safety profile, as no adverse events are reported. This includes programs like inspiratory muscle training and expiratory muscle strength training, which have shown significant improvements in symptoms and functional performance. ^{1 2 3 4 5}

Is the Home-Based Respiratory Muscle Strength Training Program a promising treatment for shortness of breath after COVID-19?

Yes, the Home-Based Respiratory Muscle Strength Training Program is promising for treating shortness of breath after COVID-19. Studies show it improves breathing, physical performance, and quality of life for people with ongoing symptoms after COVID-19. It is also an affordable and effective option that can be done at home. ^{1 2 3 4 6}

What is the purpose of this trial?

To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory breathing exercises compared to expiratory breathing exercises alone will help to improve shortness of breath, respiratory symptoms, breathing function, distance walked, and quality of life in those who are experiencing persistent shortness of breath after having had COVID-19. Measurements will take place at the beginning, 6 weeks, and at 12 weeks in the study.

Research Team

Constance Visovsky, PhD

Principal Investigator

University of South Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Home-Based Pilot Pulmonary Program for Dyspneic Patients Post-COVID-19. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Respiratory Muscle Strength Training in Patients Post-COVID-19: A Systematic Review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of home-based inspiratory muscle training in patients post-covid-19: Protocol for a randomized clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. [2019]

6. Italy 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. [2023]