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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
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.
Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy
New York, New York, United States
RECRUITINGHeart rate and rhythm response to exercise and positional changes
Heart rate and rhythm will be measured using 3-lead ECG telemetry
Time frame: Up to 24-weeks
Blood pressure response to exercise and positional changes
Blood pressure will be measured via manual cuff
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 24-weeks
Post-acute COVID symptoms (PACS)
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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).
Time frame: 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.
Time frame: Up to 24-weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24-weeks