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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
prospective randomized clinical study with 2 arms
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
arm 1 		Participants randomized to usual care
  • 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
Experimental
arm 2 		participants randomize to diaphragmatic breathing (DB) program
  • Other: Specific DB program/Diaphragmatic manipulation program
    12 weeks of 2 sessions/week: one session will be remote and one in-person

Recruiting Locations

University of Minnesota
Minneapolis, Minnesota 55414
Contact:
Farah Ikramuddin
ikram002@umn.edu

More Details

NCT ID
NCT06330376
Status
Recruiting
Sponsor
University of Minnesota

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.