Cardiopulmonary Rehabilitation in COVID-19 Longhaulers

Covid19 Clinical Trial

Official title:

Cardiopulmonary Rehabilitation in COVID-19 Longhaulers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898205
• Other study ID #: PLM UD 2021
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: May 2021
• Source: Pulmonary Wellness Foundation
• Contact: Noah Greenspan, DPT
• Phone: (212) 249-0904
• Email: consult[@]covidpt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Covid19
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Noah Greenspan	University of Dayton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Blood pressure response to exercise and positional changes	Blood pressure will be measured via manual cuff	Up to 24-weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Up to 24-weeks
Secondary	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.	Up to 24-weeks
Secondary	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.	Up to 24-weeks
Secondary	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.	Up to 24-weeks
Secondary	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.	Up to 24-weeks
Secondary	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.	Up to 24-weeks

External Links

•   Psychopathology, Personality, and Affective Science (PPAS) Laboratory at the University of Dayton
•   Pulmonary Wellness Foundation
•   Pulmonary Wellness Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy