Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD)

NCT06330376 | Completed

• 1 other identifier: PT-2022-30735
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Post-Acute Sequelae of COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (8)

• PHQ9: Patient health questionnaire 9

  6 months

• GAD7: Generalized anxiety disorder 7-item

  6 months

• PROMIS score: Patient-Reported Outcomes Measurement Information System

  6 months

• QoL scale: Quality of life scale

  6 months

• FACIT fatigue scale 's Fatigue score

  6 months

Study Arms (2)

arm 1

ACTIVE COMPARATOR

Participants randomized to usual care

Other: Usual care of traditional treatment

arm 2

EXPERIMENTAL

participants randomize to diaphragmatic breathing (DB) program

Other: Specific DB program/Diaphragmatic manipulation program

Interventions

Usual care of traditional treatment OTHER

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

arm 1

Specific DB program/Diaphragmatic manipulation program OTHER

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

arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Farha Ikramuddin, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized clinical study with 2 arms

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 26, 2024
• Study Start: March 1, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)