Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
24 participants
INTERVENTIONAL
2021-01-21
2022-01-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Physiology of Long COVID-19 and the Impact of Cardiopulmonary Rehabilitation on Quality-of-Life and Functional Capacity
NCT05566483
The Effect of Home-based Rehabilitation Program After COVID-19 Infection
NCT05317975
Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Atrial Fibrillation Patients
NCT07270757
The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury
NCT06404411
Effect of a Virtually Implemented Cardiac Rehabilitation Program
NCT05201976
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treadmill Exercise with Supplemental Oxygen
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.
Treadmill Exercise
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 Oxygen
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
Treadmill Exercise with Air
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.
Treadmill Exercise
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 Oxygen
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
Concentrated Air
Room air will be delivered through an concentrator provided via nasal cannula.
Supplemental Oxygen Only
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.
Treadmill Exercise
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 Oxygen
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
No Intervention
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.
Treadmill Exercise
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 Oxygen
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
Concentrated Air
Room air will be delivered through an concentrator provided via nasal cannula.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treadmill Exercise
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 Oxygen
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
Concentrated Air
Room air will be delivered through an concentrator provided via nasal cannula.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
1. Acute myocardial infarction within the past two days
2. Ongoing unstable angina
3. Uncontrolled cardiac arrhythmias
4. Active endocarditis
5. Symptomatic severe aortic stenosis
6. Decompensated heart failure
7. Active pulmonary embolism, pulmonary infarction, or deep venous thrombosis
8. Active myocarditis or pericarditis
9. Acute aortic dissection
10. 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Dayton
OTHER
Noah Greenspan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Noah Greenspan
Founder
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Noah Greenspan, DPT
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Wellness Foundation
Julie Walsh-Messinger, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Dayton
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Pulmonary Wellness Foundation
Pulmonary Wellness Post-COVID Rehabilitation and Recovery Clinic at H\&D Physical Therapy
Psychopathology, Personality, and Affective Science (PPAS) Laboratory at the University of Dayton
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PLM UD 2021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.