24 Participants Needed

Breathing Exercises for Post-COVID Syndrome

FI
Overseen ByFarha Ikramuddin, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen in many conditions including following intubation, lung disease, prolonged ventilation, neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmatic dysfunction in patients with COVID19 are critical illness myopathy, ventilator-induced diaphragm dysfunction, iatrogenic phrenic nerve injury particularly secondary to line placement, post-infectious inflammatory neuropathy of the phrenic nerve, or possibly direct neuromuscular involvement of the SARS- CoV-2 virus given expression of the angiotensin- converting enzyme 2 (ACE2) receptor in the peripheral nervous system and skeletal muscle. The use of diaphragmatic ultrasound has been widely used to assess diaphragmatic function is well known in patients following prolonged mechanical ventilation. Prolonged mechanical ventilation leads to contractile dysfunction of respiratory muscles, in particular the diaphragm, causing a so-called ventilator-induced diaphragm dysfunction. The latter is defined as a loss of diaphragm force-generating capacity specifically related to the use of mechanical ventilation. However, the use of diaphragmatic Ultrasound to assess its function in Long COVID patients has not been noted and is a gap in the work up of these patients. The purpose of this study is to address Diaphragmatic Dysfunctional (DD) breathing seen in patients with Post-Acute Sequelae of COVID-19 (PASC), which results in shortness of breath/chest tightness and subsequent fatigue. Targeting shortness of breath and subsequent fatigue as a central symptom of PASC will alleviate long term sequelae for the patients with PASC. DD will be addressed by a unique intervention of physical therapy. The goal of this prospective randomized clinical study will be to evaluate the comparative treatment effect of DB on markers, specifically fatigue, dyspnea, 6 min walk test, depression/anxiety, and quality of life (QoL).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have a stable dose of antidepressants prior to COVID-19 infection, suggesting that some medications may be continued if they are stable.

What data supports the effectiveness of the treatment Diaphragmatic Breathing Exercises for Post-COVID Syndrome?

Research shows that breathing exercises, including diaphragmatic breathing, can improve lung function, quality of life, and exercise capacity in people recovering from COVID-19. Studies found significant improvements in breathing ability and physical performance when these exercises were done regularly, even when delivered through telemedicine.12345

Is it safe to do breathing exercises for post-COVID syndrome?

Breathing exercises, including diaphragmatic breathing and deep breathing, have been studied in various conditions and are generally considered safe for humans. They have been shown to improve lung function and quality of life without reported safety concerns in studies involving post-COVID-19 patients and those with other respiratory conditions.13678

How do diaphragmatic breathing exercises differ from other treatments for post-COVID syndrome?

Diaphragmatic breathing exercises are unique because they focus on strengthening the diaphragm (the main muscle used in breathing) and improving breathing patterns, which can be done easily at home or via telemedicine. Unlike other treatments that may require equipment or in-person sessions, these exercises can be self-administered and are particularly beneficial for improving lung function and quality of life in post-COVID patients.135910

Research Team

FI

Farha Ikramuddin, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for individuals experiencing diaphragmatic dysfunction after COVID-19, which includes symptoms like shortness of breath and fatigue. Participants should have a history of COVID-19 and be facing ongoing respiratory issues.

Inclusion Criteria

Patients did not need hospitalization of 5 days or more and did not need ICU admission via chart review or history taking
PCR or home kit positive 4 weeks prior to the development of the PASC symptoms
I experience shortness of breath, chest tightness, or fatigue.
See 2 more

Exclusion Criteria

My anxiety medication and dosage have been stable for the last 4 weeks.
I cannot move my shoulders fully.
Individual or group with a serious health condition for which there are no satisfactory standard treatments
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo diaphragmatic breathing exercises to address diaphragmatic dysfunction and improve symptoms such as fatigue and dyspnea

6 months
Regular visits for assessment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, depression, anxiety, and physical health

6 months

Treatment Details

Interventions

  • Diaphragmatic Breathing Exercises
Trial Overview The study tests two approaches to treat post-COVID diaphragmatic dysfunction: a specific Diaphragmatic Breathing (DB) program with manipulation techniques versus traditional care methods. The goal is to see which method better improves breathing, reduces fatigue, and enhances quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: arm 2Experimental Treatment1 Intervention
participants randomize to diaphragmatic breathing (DB) program
Group II: arm 1Active Control1 Intervention
Participants randomized to usual care

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

Breathing exercises delivered via telemedicine significantly improved pulmonary function and exercise capacity in post-Covid-19 individuals, with the intervention group showing marked increases in FEV1, FVC, and MVV values after 5 weeks of training.
Participants in the intervention group also increased their six-minute walk distance by an average of 54.27 meters, compared to only 4.69 meters in the control group, highlighting the efficacy of telemedicine-based breathing exercises in enhancing quality of life for those experiencing dyspnea.
Evaluating the Efficiency of Breathing Exercises via Telemedicine in Post-Covid-19 Patients: Randomized Controlled Study.Okan, F., Okan, S., Duran Yücesoy, F.[2022]
Diaphragm function was significantly impaired in patients hospitalized with COVID-19, but showed marked improvement over time, with thickening fraction (TF) increasing from 0.56 at admission to 1.54 after 12 months, indicating a prolonged recovery period.
The study involved 49 patients, with 28 completing a 1-year follow-up, suggesting that diaphragm ultrasound could be an important tool for monitoring diaphragm function in post-COVID-19 patients.
Sonographic follow-up of diaphragm function in COVID-19: an exploratory study.Veldman, C., de Boer, WS., Kerstjens, HAM., 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.
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

Evaluating the Efficiency of Breathing Exercises via Telemedicine in Post-Covid-19 Patients: Randomized Controlled Study. [2022]
Sonographic follow-up of diaphragm function in COVID-19: an exploratory study. [2023]
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]
Home-Based Pilot Pulmonary Program for Dyspneic Patients Post-COVID-19. [2023]
Pulmonary Rehabilitation in COVID-19 patients: A scoping review of current practice and its application during the pandemic. [2020]
Effects of Breathing Exercises in Patients With Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-Analysis. [2020]
Respiratory Muscle Strength Training in Patients Post-COVID-19: A Systematic Review. [2023]
Influence of Manual Diaphragm Release Technique Combined with Inspiratory Muscle Training on Selected Persistent Symptoms in Men with Post-Covid-19 Syndrome: A Randomized Controlled Trial. [2022]
Modified rehabilitation exercises for mild cases of COVID-19. [2020]
Pulmonary recovery directly after COVID-19 and in Long-COVID. [2023]
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