- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04898205
Cardiopulmonary Rehabilitation in COVID-19 Longhaulers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noah Greenspan, DPT
- Phone Number: (212) 249-0904
- Email: consult@covidpt.org
Study Contact Backup
- Name: Julie Walsh-Messinger, Ph.D.
- Phone Number: (937) 229-1380
- Email: udcovidstudy@udayton.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10017
- Recruiting
- Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy
-
Contact:
- Noah Greenspan, DPT
- Phone Number: 212-921-0214
- Email: consult@covidpt.org
-
Contact:
- Julie Walsh-Messinger, PhD
- Phone Number: (937) 229-1380
- Email: udcovidstudy@udayton.edu
-
Principal Investigator:
- Noah Greenspan, DPT, CCS
-
Principal Investigator:
- Julie Walsh-Messinger, PhD
-
Sub-Investigator:
- Marion Mackles, BS, PT
-
Sub-Investigator:
- Marcella Debidda, PhD
-
Sub-Investigator:
- Robert Kaner, MD
-
Sub-Investigator:
- Louis DePalo, MD
-
Sub-Investigator:
- Gregory Hullstrung, PT, FAFS
-
Sub-Investigator:
- Wai Chin, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 Names:
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
|
Sham Comparator: 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.
|
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 Names:
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
Room air will be delivered through an concentrator provided via nasal cannula.
|
Sham Comparator: 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.
|
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 Names:
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
|
Placebo Comparator: 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.
|
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 Names:
Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
Room air will be delivered through an concentrator provided via nasal cannula.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 24-weeks
|
Blood pressure response to exercise and positional changes
Time Frame: Up to 24-weeks
|
Blood pressure will be measured via manual cuff
|
Up to 24-weeks
|
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.
|
Up to 24-weeks
|
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
|
Up to 24-weeks
|
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.
|
Up to 24-weeks
|
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.
|
Up to 24-weeks
|
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).
|
Up to 24-weeks
|
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.
|
Up to 24-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Up to 24-weeks
|
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.
|
Up to 24-weeks
|
Generalized anxiety
Time Frame: Up to 24-weeks
|
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.
|
Up to 24-weeks
|
State anxiety
Time Frame: Up to 24-weeks
|
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.
|
Up to 24-weeks
|
Trait anxiety
Time Frame: Up to 24-weeks
|
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.
|
Up to 24-weeks
|
Improvement in quality of life
Time Frame: Up to 24-weeks
|
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. |
Up to 24-weeks
|
Perception of cognitive function
Time Frame: Up to 24-weeks
|
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. |
Up to 24-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Noah Greenspan, DPT, Pulmonary Wellness Foundation
- Principal Investigator: Julie Walsh-Messinger, Ph.D., University of Dayton
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLM UD 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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