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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
16
Usual care of traditional treatment which is PT and/or OT when indicated Followed by Pulmonary rehabilitation when indicated
12 weeks of 2 sessions/week: one session will be remote and one in-person
University of Minnesota
Minneapolis, Minnesota, United States
6-minute walk test (6MWT)
It is a simple test that requires no specialized equipment or advanced training for physicians and assesses the submaximal level of functional capacity of an individual while walking on a flat, hard surface in a period of 6 min. It is used to assess the response to a medical therapy, and in cardiac/pulmonary rehabilitation.
Time frame: 6 months
PHQ9: Patient health questionnaire 9
measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.
Time frame: 6 months
GAD7: Generalized anxiety disorder 7-item
measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.
Time frame: 6 months
PROMIS score: Patient-Reported Outcomes Measurement Information System
is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Administration of these scales is a standard of care in our post-COVID clinic.
Time frame: 6 months
QoL scale: Quality of life scale
measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.
Time frame: 6 months
FACIT fatigue scale 's Fatigue score
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (FACIT) FACIT fatigue scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) 18 The FACIT Fatigue Scale is one of many different FACIT scales that are part of a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness referred to as The FACIT Measurement System.
Time frame: 6 months
Modified Borg dyspnea scale
The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT).
Time frame: 6 months
RR; respiratory rate with 6 min walk test
Time frame: 6 months
PR: pulse rate with 6 min walk test
Time frame: 6 months
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