Official Title
Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD)
Brief Summary

Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen inmany conditions including following intubation, lung disease, prolonged ventilation,neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmaticdysfunction in patients with COVID19 are critical illness myopathy, ventilator-induceddiaphragm dysfunction, iatrogenic phrenic nerve injury particularly secondary to lineplacement, post-infectious inflammatory neuropathy of the phrenic nerve, or possiblydirect neuromuscular involvement of the SARS- CoV-2 virus given expression of theangiotensin- converting enzyme 2 (ACE2) receptor in the peripheral nervous system andskeletal muscle. The use of diaphragmatic ultrasound has been widely used to assessdiaphragmatic function is well known in patients following prolonged mechanicalventilation. Prolonged mechanical ventilation leads to contractile dysfunction ofrespiratory muscles, in particular the diaphragm, causing a so-called ventilator-induceddiaphragm dysfunction. The latter is defined as a loss of diaphragm force-generatingcapacity specifically related to the use of mechanical ventilation. However, the use ofdiaphragmatic Ultrasound to assess its function in Long COVID patients has not been notedand is a gap in the work up of these patients.The purpose of this study is to address Diaphragmatic Dysfunctional (DD) breathing seenin patients with Post-Acute Sequelae of COVID-19 (PASC), which results in shortness ofbreath/chest tightness and subsequent fatigue. Targeting shortness of breath andsubsequent fatigue as a central symptom of PASC will alleviate long term sequelae for thepatients 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 thecomparative treatment effect of DB on markers, specifically fatigue, dyspnea, 6 min walktest, depression/anxiety, and quality of life (QoL).

Detailed Description

Not Provided

Recruiting
Post-Acute Sequelae of COVID-19

Other: Usual care of traditional treatment

Usual care of traditional treatment which is PT and/or OT when indicated Followed by
Pulmonary rehabilitation when indicated

Other: Specific DB program/Diaphragmatic manipulation program

12 weeks of 2 sessions/week: one session will be remote and one in-person

Eligibility Criteria

Inclusion Criteria:

- Male or female age 18 and above

- PCR or home kit positive 4 weeks prior to the development of the PASC symptoms

- new diagnosis of PASC (defined as new-onset symptoms of fatigue, shortness of
breath, chest tightness or persistence of symptoms 4 weeks following a positive PCR
test for COVID-19)

- patients did not need hospitalization of 5 days or more and did not need ICU
admission via chart review or history taking.

- nose breathers as reported by patient at the time of screening by history taking

- symptoms should include shortness of breath/chest tightness/fatigue

Exclusion Criteria:

- pre-existing lung disease such as COPD, IPF, Asthma, Exercise induced Asthma, Lung
cancer, or history of Lung transplant

- history of current smoking and pack years of 10

- history of coronary artery disease

- general anxiety disorder without changes in medication and dosage for treatment in
the last 4 weeks.

- unable to have full range of motion of the shoulders

- stable dose of antidepressants prior to covid-19 infection

- Pregnant women/fetuses/neonates via self-report.

- non-English speakers

- patients with previously diagnosed severe cognitive deficits such as dementia,
developmental defects, those with acute medical conditions, psychiatric disorders
such as schizophrenia, mania, and psychosis, neurologic disorders such as stroke,
Parkinson's disease and Multiple sclerosis

- unable to read

- Individual or group with a serious health condition for which there are no
satisfactory standard treatments

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of Minnesota
Minneapolis, Minnesota, United States

Investigator: Farah Ikramuddin
ikram002@umn.edu

Contacts

Farha Ikramuddin, MD
952-905-9803
ikram002@umn.edu

Farha Ikramuddin, MD, Principal Investigator
University of Minnesota

University of Minnesota
NCT Number
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome