Post-Acute Sequelae of COVID-19NCT06330376
Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD)
A study testing Specific DB program/Diaphragmatic manipulation program in people with Post-Acute Sequelae of COVID-19, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Acute Sequelae of COVID-19
- What is being tested?
- Specific DB program/Diaphragmatic manipulation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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
- Being tested
- Usual care of traditional treatment, Specific DB program/Diaphragmatic manipulation program
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care of traditional treatmentOther
Usual care of traditional treatment which is PT and/or OT when indicated Followed by Pulmonary rehabilitation when indicated
Specific DB program/Diaphragmatic manipulation programOther
12 weeks of 2 sessions/week: one session will be remote and one in-person
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Active comparator | Participants randomized to usual care Receives: Other: Usual care of traditional treatment |
| arm 2 | Experimental | participants randomize to diaphragmatic breathing (DB) program Receives: Other: Specific DB program/Diaphragmatic manipulation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
PHQ9: Patient health questionnaire 9
measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 months
RR; respiratory rate with 6 min walk test
Measured: 6 months
PR: pulse rate with 6 min walk test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Mar 2024
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute Sequelae of COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized clinical study with 2 arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farha Ikramuddin, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330376
- Sponsor's protocol ID
- PT-2022-30735
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD)
- ClinicalTrials.gov ID
- NCT06330376
- Acronym / sponsor ID
- PT-2022-30735
- Conditions
- Post-Acute Sequelae of COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized clinical study with 2 arms
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Active comparator | Other: Usual care of traditional treatmentParticipants randomized to usual care |
| arm 2 | Experimental | Other: Specific DB program/Diaphragmatic manipulation programparticipants randomize to diaphragmatic breathing (DB) program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care of traditional treatmentUsual care of traditional treatment which is PT and/or OT when indicated Followed by Pulmonary rehabilitation when indicated | Other | arm 1 |
| Specific DB program/Diaphragmatic manipulation program12 weeks of 2 sessions/week: one session will be remote and one in-person | Other | arm 2 |
Primary outcome
6-minute walk test (6MWT)
Time frame: 6 months
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.
8 secondary outcomes
PHQ9: Patient health questionnaire 9
Time frame: 6 months
GAD7: Generalized anxiety disorder 7-item
Time frame: 6 months
PROMIS score: Patient-Reported Outcomes Measurement Information System
Time frame: 6 months
QoL scale: Quality of life scale
Time frame: 6 months
FACIT fatigue scale 's Fatigue score
Time frame: 6 months
Modified Borg dyspnea scale
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Post-Acute Sequelae of COVID-19
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SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
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Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Active, not recruiting
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Dysexecutive Syndrome, Post-Acute Sequelae of COVID-19
Not yet recruitingPhase 1/2
Taurine Supplementation in Adolescents With Post-COVID Condition
Long COVID, Post COVID-19 Condition
Active, not recruitingObservational study
Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 (PASC) Using TSPO Positron Emission Tomography (PET) and MRI
Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farha Ikramuddin, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific DB program/Diaphragmatic manipulation program in people with Post-Acute Sequelae of COVID-19, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (6MWT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.