Cardiopulmonary Rehabilitation in COVID-19 Longhaulers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Noah Greenspan
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Breathlessness
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Noah Greenspan
Founder
Pulmonary Wellness Foundation
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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).
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
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.
Blood pressure response to exercise and positional changes
Time Frame: Up to 24-weeks
Blood pressure will be measured via manual cuff
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.
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.
Secondary Outcomes
- Trait anxiety(Up to 24-weeks)
- Perception of cognitive function(Up to 24-weeks)
- Generalized anxiety(Up to 24-weeks)
- Depression(Up to 24-weeks)
- Improvement in quality of life(Up to 24-weeks)
- State anxiety(Up to 24-weeks)