Covid19NCT04898205
Cardiopulmonary Rehabilitation in COVID-19 Longhaulers
A study testing Treadmill Exercise, Concentrated Oxygen and Concentrated Air in people with Covid19 and Viral Syndrome, run by Noah Greenspan at 1 site in United States.
Trial summary
This study will test the efficacy of treadmill exercise combined with supplemental oxygen during exercise and recovery for the treatment of persistent post-acute COVID-19 symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Covid19, Viral Syndrome
- What is being tested?
- Treadmill Exercise, Concentrated Oxygen and Concentrated Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 20 Jan 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-60
- Contracted COVID-19 between February - July 2020
- Has been clinician-diagnosed with COVID-19 based on PCR/antigen testing, antibody testing, or clinical symptoms
- Is currently experiencing one or more of the following symptoms, which began only after contracting COVID-19 : dyspnea, cough, chest pain, tachycardia or other arrhythmias, hypertension, hypotension, blood pressure lability, oxygen desaturation, exercise/activity intolerance, fatigue, or dizziness.
- Has been cleared by a physician for exercise and supplemental oxygen.
- Has the capacity to provide written, informed consent
- Able to complete questionnaires in English
Who cannot join
- History of any of the following per the American College of Sports Medicine exercise testing guidelines (American College of Sports Medicine et al., 2018) to be determined during a screening consultation:
- Acute myocardial infarction within the past two days
- Ongoing unstable angina
- Uncontrolled cardiac arrhythmias
- Active endocarditis
- Symptomatic severe aortic stenosis
Show all 12Show fewer
- Decompensated heart failure
- Active pulmonary embolism, pulmonary infarction, or deep venous thrombosis
- Active myocarditis or pericarditis
- Acute aortic dissection
- Physical disability that precludes safe and adequate testing
- Participants who demonstrate orthostatic intolerance or oxygen desaturation (<90%) during the exercise tolerance test will no longer be eligible for the study because it is not safe for them to exercise on a treadmill.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy
New York, New York, 10017
Noah Greenspan, DPT, 212-921-0214, consult@covidpt.org
Julie Walsh-Messinger, PhD, (937) 229-1380, udcovidstudy@udayton.edu
About this study
This study will test the efficacy of treadmill exercise combined with supplemental oxygen during exercise and recovery for the treatment of persistent post-acute COVID-19 symptoms. Participants will be pseudo-randomized (stratified by age) to one of four conditions for 8 treatment sessions: 1) treadmill exercise plus supplemental oxygen, 2) treadmill exercise plus air, 3) supplemental oxygen only, 4) air only. All participants will then cross-over and receive 16 additional sessions of treadmill exercise plus supplemental oxygen.
Read the detailed description
This study will test the efficacy of a COVID-19 specific cardiopulmonary rehabilitation protocol for treatment of persistent post-acute COVID symptoms and to study the impact of cardiopulmonary improvement on cognition, mental health, and function. Participants (N=36) with persistent post-acute COVID symptoms will undergo pre-treatment neurocognitive, orthostatic tolerance, and exercise tolerance tests before being pseudo-randomized (stratified by age and sex) to one of four conditions (all of which occur twice a week): 1) 8 sessions of treadmill exercise plus supplemental oxygen, 2) 8 sessions of treadmill exercise plus air, 3) 8 sessions of supplemental oxygen only, and 4) 8 sessions of air only. The pre-treatment testing will be repeated, after which all participants will receive 16 additional sessions of treadmill exercise plus supplemental oxygen, followed by post-treatment testing. All participants will complete baseline measures of physical and mental health, physical function, emotional wellbeing, and coping. A brief symptom measure will be collected daily and physical function, mental health, and emotional wellbeing will be assessed weekly.
- Conditions
- Covid19, Viral Syndrome
- Being tested
- Treadmill Exercise, Concentrated Oxygen, Concentrated Air
- Keywords
- Post-COVID Syndrome, Post-acute COVID, Long COVID
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill ExerciseOther
Also called Supplemental oxygen (6 liters per minute)
The cardiopulmonary rehabilitation protocol utilizes progressive treadmill exercise with alternating increases in intensity and incline with no more than 0.5 Met increase per session.
Concentrated OxygenOther
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
Concentrated AirOther
Room air will be delivered through an concentrator provided via nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Exercise with Supplemental Oxygen | Experimental | Participants will receive 24 sessions (2 x week for 12 weeks) of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. Receives: Other: Treadmill Exercise; Other: Concentrated Oxygen |
| Treadmill Exercise with Air | Sham comparator | Participants will receive 8 sessions (2 x week for 4 weeks) of treadmill exercise combined with air delivered via nasal cannula during exercise and 5-minutes of recovery. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. Receives: Other: Treadmill Exercise; Other: Concentrated Oxygen; Other: Concentrated Air |
| Supplemental Oxygen Only | Sham comparator | Participants will receive 8 treatment sessions (2 x week for 4 weeks) of 6 liters per minute of continuous oxygen via nasal cannula for 30 minutes at rest. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three minutes. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. Receives: Other: Treadmill Exercise; Other: Concentrated Oxygen |
| No Intervention | Placebo comparator | Participants will receive 8 treatment sessions (2 x week for 4 weeks) of air via nasal cannula for 30 minutes at rest. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three minutes. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. Receives: Other: Treadmill Exercise; Other: Concentrated Oxygen; Other: Concentrated Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate and rhythm response to exercise and positional changes
Heart rate and rhythm will be measured using 3-lead ECG telemetry
Measured: Up to 24-weeks
Blood pressure response to exercise and positional changes
Blood pressure will be measured via manual cuff
Measured: Up to 24-weeks
Activity metabolic equivalent of task (MET) tolerated
MET will be computed based upon peak exercise speed (MPH) and incline % gradation). Scores are expected to range from 1.8 to 12.1 (but can be higher is speed exceeds 3.9 MPH). Higher METs indicate more energy output.
Measured: Up to 24-weeks
Breathlessness
Breathlessness will be assessed during peak exercise via self-report using the Borg Dyspnea scale. Scores can range from 0 to 20 and higher scores indicate more breathlessness
Measured: Up to 24-weeks
Rate of perceived exertion (RPE)
RPE will be assessed during peak exercise via self-report using the Borg RPE scale. Scores can range from 0 to 20 and higher scores indicate more RPE.
Measured: Up to 24-weeks
Cognition (attention, short, delayed, and working memory, verbal fluency, and abstraction).
Cognition will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS-U) List Learning, List Recall, List Recognition, Story Memory, Story Recall, Semantic Fluency and Picture Naming subtests and the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Similarities and Digit Span subtests. All scores will be standard scores based on age norms.
Measured: Up to 24-weeks
Post-acute COVID symptoms (PACS)
Frequency and severity of 38 PACS symptoms will be assessed daily via an online survey. Each symptom will be rated on a scale of 0 (not present) to 5 (severe).
Measured: Up to 24-weeks
Physical Function
Physical function will be measured weekly via self-report with the Physical Function Short Form-36. Scores can range from 0 to 100 and higher scores indicate better function.
Measured: Up to 24-weeks
Secondary outcomes (6)
Depression
Depression will be measured weekly with the Center for Epidemiological Studies Depression Scale - Revised (CESD-R). Scores range from 0 to 60 and higher scores indicate greater depression severity.
Measured: Up to 24-weeks
Generalized anxiety
Generalized anxiety will be measured weekly using the Generalized Anxiety Disorder - 2 (GAD-2). Scores range from 0 to 6 and higher scores indicate greater anxiety severity.
Measured: Up to 24-weeks
State anxiety
Anxiety will be measured weekly using the State Trait Anxiety Inventory (STAI) - State scale. Scale scores range from 20 to 80, with higher scores indicating greater state anxiety.
Measured: Up to 24-weeks
Trait anxiety
Trait anxiety will be measured weekly using the State Trait Anxiety Inventory (STAI) - Trait scale. Scores can range from 20 to 80, with higher scores indicating greater trait anxiety.
Measured: Up to 24-weeks
Improvement in quality of life
Quality of life will be measured weekly with the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). Raw scores range from 14 to 70 and will be converted to a percentage score based on the following formula:
(raw total score -minimum score)/(maximum possible raw score -minimum score). Higher scores indicate greater life satisfaction.
Measured: Up to 24-weeks
Perception of cognitive function
Perception of cognitive function will be assessed with the Neuro-QOL Cognitive function subscale which measures self-reported cognitive functioning over the past week, including perceptions of memory, executive functions, processing speed, and learning. Raw scores can range from 8 to 40, and will be converted to T-scores based on the administration manual norms. Higher scores indicated better perceived cognitive function.
We have modified the baseline administration to also assess whether perceived cognitive function has changed since onset of acute COVID-19.
Measured: Up to 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start21 Jan 2021
- Primary completion20 Jan 2022 (estimated)
- Study completion20 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Crossover
- Model description
- This study entails 24 treatment sessions. The first 8 sessions involve four experimental conditions: 1) exercise + oxygen (treatment), exercise + air (active control), oxygen only (active control), air only (placebo). Pre-treatment testing will then be repeated, after which all participants will crossover to 16 sessions of exercise + oxygen.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noah Greenspan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dayton
- Responsible party
- Sponsor-investigator, Noah Greenspan, Pulmonary Wellness Foundation
- Investigators
- Noah Greenspan, DPT, Principal investigator, Pulmonary Wellness FoundationJulie Walsh-Messinger, Ph.D., Principal investigator, University of Dayton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898205
- Sponsor's protocol ID
- PLM UD 2021
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon conclusion of the study, we will share de-identified data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Rehabilitation in COVID-19 Longhaulers
- ClinicalTrials.gov ID
- NCT04898205
- Acronym / sponsor ID
- PLM UD 2021
- Conditions
- Covid19, Viral Syndrome
- Keywords
- Post-COVID Syndrome, Post-acute COVID, Long COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Noah GreenspanUniversity, hospital or other
- Collaborators
- University of Dayton
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 20 Jan 2022 (estimated)
- Study completion
- 20 Jan 2022 (estimated)
- First posted
- 24 May 2021 (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.
This study will test the efficacy of treadmill exercise combined with supplemental oxygen during exercise and recovery for the treatment of persistent post-acute COVID-19 symptoms. Participants will be pseudo-randomized (stratified by age) to one of four conditions for 8 treatment sessions: 1) treadmill exercise plus supplemental oxygen, 2) treadmill exercise plus air, 3) supplemental oxygen only, 4) air only. All participants will then cross-over and receive 16 additional sessions of treadmill exercise plus supplemental oxygen.
Detailed description
This study will test the efficacy of a COVID-19 specific cardiopulmonary rehabilitation protocol for treatment of persistent post-acute COVID symptoms and to study the impact of cardiopulmonary improvement on cognition, mental health, and function. Participants (N=36) with persistent post-acute COVID symptoms will undergo pre-treatment neurocognitive, orthostatic tolerance, and exercise tolerance tests before being pseudo-randomized (stratified by age and sex) to one of four conditions (all of which occur twice a week): 1) 8 sessions of treadmill exercise plus supplemental oxygen, 2) 8 sessions of treadmill exercise plus air, 3) 8 sessions of supplemental oxygen only, and 4) 8 sessions of air only. The pre-treatment testing will be repeated, after which all participants will receive 16 additional sessions of treadmill exercise plus supplemental oxygen, followed by post-treatment testing. All participants will complete baseline measures of physical and mental health, physical function, emotional wellbeing, and coping. A brief symptom measure will be collected daily and physical function, mental health, and emotional wellbeing will be assessed weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study entails 24 treatment sessions. The first 8 sessions involve four experimental conditions: 1) exercise + oxygen (treatment), exercise + air (active control), oxygen only (active control), air only (placebo). Pre-treatment testing will then be repeated, after which all participants will crossover to 16 sessions of exercise + oxygen.
| Arm | Type | Receives |
|---|---|---|
| Treadmill Exercise with Supplemental Oxygen | Experimental | Other: Treadmill Exercise, Other: Concentrated OxygenParticipants will receive 24 sessions (2 x week for 12 weeks) of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. |
| Treadmill Exercise with Air | Sham comparator | Other: Treadmill Exercise, Other: Concentrated Oxygen, Other: Concentrated AirParticipants will receive 8 sessions (2 x week for 4 weeks) of treadmill exercise combined with air delivered via nasal cannula during exercise and 5-minutes of recovery. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. |
| Supplemental Oxygen Only | Sham comparator | Other: Treadmill Exercise, Other: Concentrated OxygenParticipants will receive 8 treatment sessions (2 x week for 4 weeks) of 6 liters per minute of continuous oxygen via nasal cannula for 30 minutes at rest. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three minutes. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. |
| No Intervention | Placebo comparator | Other: Treadmill Exercise, Other: Concentrated Oxygen, Other: Concentrated AirParticipants will receive 8 treatment sessions (2 x week for 4 weeks) of air via nasal cannula for 30 minutes at rest. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three minutes. They will then cross-over to 16 sessions of treadmill exercise combined with 6 liters per minute of supplemental oxygen via nasal cannula during exercise and 5-minutes of recovery. The first treadmill session will last 25% longer than the exercise tolerance test, but at a lower intensity, such that 80-100% of peak exercise intensity calculated from the exercise tolerance test MET is achieved within three sessions, after which time and intensity will be increased by no more than 0.5 METS, as tolerated based on symptoms and vitals. Heart rate, rhythm, and oxygen saturation will be continuously monitored, and blood pressure readings will be obtained every three to five minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between the ages of 18-60
- Contracted COVID-19 between February - July 2020
- Has been clinician-diagnosed with COVID-19 based on PCR/antigen testing, antibody testing, or clinical symptoms
- Is currently experiencing one or more of the following symptoms, which began only after contracting COVID-19 : dyspnea, cough, chest pain, tachycardia or other arrhythmias, hypertension, hypotension, blood pressure lability, oxygen desaturation, exercise/activity intolerance, fatigue, or dizziness.
- Has been cleared by a physician for exercise and supplemental oxygen.
Key exclusion criteria (12 listed)
- History of any of the following per the American College of Sports Medicine exercise testing guidelines (American College of Sports Medicine et al., 2018) to be determined during a screening consultation:
- Participants who demonstrate orthostatic intolerance or oxygen desaturation (<90%) during the exercise tolerance test will no longer be eligible for the study because it is not safe for them to exercise on a treadmill.
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 |
|---|---|---|
| Treadmill ExerciseAlso: Supplemental oxygen (6 liters per minute)The cardiopulmonary rehabilitation protocol utilizes progressive treadmill exercise with alternating increases in intensity and incline with no more than 0.5 Met increase per session. | Other | No Intervention, Supplemental Oxygen Only, Treadmill Exercise with Air, Treadmill Exercise with Supplemental Oxygen |
| Concentrated OxygenSupplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation. | Other | No Intervention, Supplemental Oxygen Only, Treadmill Exercise with Air, Treadmill Exercise with Supplemental Oxygen |
| Concentrated AirRoom air will be delivered through an concentrator provided via nasal cannula. | Other | No Intervention, Treadmill Exercise with Air |
Primary outcome
Heart rate and rhythm response to exercise and positional changes
Time frame: Up to 24-weeks
Heart rate and rhythm will be measured using 3-lead ECG telemetry
Blood pressure response to exercise and positional changes
Time frame: Up to 24-weeks
Blood pressure will be measured via manual cuff
Activity metabolic equivalent of task (MET) tolerated
Time frame: Up to 24-weeks
MET will be computed based upon peak exercise speed (MPH) and incline % gradation). Scores are expected to range from 1.8 to 12.1 (but can be higher is speed exceeds 3.9 MPH). Higher METs indicate more energy output.
Breathlessness
Time frame: Up to 24-weeks
Breathlessness will be assessed during peak exercise via self-report using the Borg Dyspnea scale. Scores can range from 0 to 20 and higher scores indicate more breathlessness
Rate of perceived exertion (RPE)
Time frame: Up to 24-weeks
RPE will be assessed during peak exercise via self-report using the Borg RPE scale. Scores can range from 0 to 20 and higher scores indicate more RPE.
Cognition (attention, short, delayed, and working memory, verbal fluency, and abstraction).
Time frame: Up to 24-weeks
Cognition will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS-U) List Learning, List Recall, List Recognition, Story Memory, Story Recall, Semantic Fluency and Picture Naming subtests and the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Similarities and Digit Span subtests. All scores will be standard scores based on age norms.
Post-acute COVID symptoms (PACS)
Time frame: Up to 24-weeks
Frequency and severity of 38 PACS symptoms will be assessed daily via an online survey. Each symptom will be rated on a scale of 0 (not present) to 5 (severe).
Physical Function
Time frame: Up to 24-weeks
Physical function will be measured weekly via self-report with the Physical Function Short Form-36. Scores can range from 0 to 100 and higher scores indicate better function.
6 secondary outcomes
Depression
Time frame: Up to 24-weeks
Generalized anxiety
Time frame: Up to 24-weeks
State anxiety
Time frame: Up to 24-weeks
Trait anxiety
Time frame: Up to 24-weeks
Improvement in quality of life
Time frame: Up to 24-weeks
Perception of cognitive function
Time frame: Up to 24-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Pulmonary Wellness FoundationLink provided by the sponsor.
- Pulmonary Wellness Post-COVID Rehabilitation and Recovery Clinic at H\&D Physical TherapyLink provided by the sponsor.
- Psychopathology, Personality, and Affective Science (PPAS) Laboratory at the University of DaytonLink provided by the sponsor.
- Individual participant dataSharing planned: No. Upon conclusion of the study, we will share de-identified data upon request.
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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.
Noah Greenspan, DPT principal investigator
Pulmonary Wellness Foundation
Julie Walsh-Messinger, Ph.D. principal investigator
University of Dayton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Exercise, Concentrated Oxygen and Concentrated Air in people with Covid19 and Viral Syndrome, run by Noah Greenspan 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 May 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noah Greenspan, DPT ((212) 249-0904, consult@covidpt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate and rhythm response to exercise and positional changes (time frame: Up to 24-weeks). The study lists 8 primary outcomes in all. 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 25 May 2021.