Cardiopulmonary Rehabilitation in COVID-19 Longhaulers

Noah Greenspan

Status: Unknown

Conditions: Viral Syndrome; Covid19

Treatments: Other: Concentrated Oxygen; Other: Treadmill Exercise; Other: Concentrated Air

Study type: Interventional

Funder types: Other

Identifiers

NCT04898205

PLM UD 2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

24 participants in 4 patient groups, including a placebo group

Treadmill Exercise with Supplemental Oxygen

Experimental group

Description:

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.

Treatment:

Other: Treadmill Exercise

Other: Concentrated Oxygen

Treadmill Exercise with Air

Sham Comparator group

Description:

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.

Treatment:

Other: Treadmill Exercise

Other: Concentrated Air

Other: Concentrated Oxygen

Supplemental Oxygen Only

Sham Comparator group

Description:

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.

Treatment:

Other: Treadmill Exercise

Other: Concentrated Oxygen

No Intervention

Placebo Comparator group

Description:

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.

Treatment:

Other: Treadmill Exercise

Other: Concentrated Air

Other: Concentrated Oxygen