Cardiopulmonary Rehabilitation in COVID-19 Longhaulers
1 other identifier
interventional
24
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Jan 2021
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2021
CompletedFirst Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedMay 25, 2021
May 1, 2021
12 months
May 17, 2021
May 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Heart rate and rhythm response to exercise and positional changes
Heart rate and rhythm will be measured using 3-lead ECG telemetry
Up to 24-weeks
Blood pressure response to exercise and positional changes
Blood pressure will be measured via manual cuff
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.
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
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.
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.
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).
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.
Up to 24-weeks
Secondary Outcomes (6)
Depression
Up to 24-weeks
Generalized anxiety
Up to 24-weeks
State anxiety
Up to 24-weeks
Trait anxiety
Up to 24-weeks
Improvement in quality of life
Up to 24-weeks
- +1 more secondary outcomes
Study Arms (4)
Treadmill Exercise with Supplemental Oxygen
EXPERIMENTALParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noah Greenspanlead
- University of Daytoncollaborator
Study Sites (1)
Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy
New York, New York, 10017, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noah Greenspan, DPT
Pulmonary Wellness Foundation
- PRINCIPAL INVESTIGATOR
Julie Walsh-Messinger, Ph.D.
University of Dayton
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- All participants will be blind to whether they receive supplemental oxygen or air during the first 8 sessions.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Founder
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 24, 2021
Study Start
January 21, 2021
Primary Completion
January 20, 2022
Study Completion
January 20, 2022
Last Updated
May 25, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
Upon conclusion of the study, we will share de-identified data upon request.