Recruiting

Cardiopulmonary Rehabilitation

Sponsor:

Noah Greenspan

Code:

NCT04898205

Conditions

Covid19

Viral Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Treadmill Exercise

Concentrated Oxygen

Concentrated Air

Study Details

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.

Conditions

Covid19

Viral Syndrome

Study ID

NCT04898205

Start date

Jan 21, 2021

Status verified date

May, 2021

Completion date

Jan 20, 2022

Anticipated

Primary completion date

Jan 20, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treadmill Exercise with Supplemental Oxygen

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.

sham comparator: Treadmill Exercise with Air

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.

sham comparator: Supplemental Oxygen Only

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.

placebo comparator: No Intervention

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.

Interventions

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.

Primary outcome measure

  • Heart rate and rhythm response to exercise and positional changes [ Time Frame: Up to 24-weeks ]
  • Blood pressure response to exercise and positional changes [ Time Frame: Up to 24-weeks ]
  • Activity metabolic equivalent of task (MET) tolerated [ Time Frame: Up to 24-weeks ]
  • Breathlessness [ Time Frame: Up to 24-weeks ]
  • Rate of perceived exertion (RPE) [ Time Frame: Up to 24-weeks ]
  • Cognition (attention, short, delayed, and working memory, verbal fluency, and abstraction). [ Time Frame: Up to 24-weeks ]
  • Post-acute COVID symptoms (PACS) [ Time Frame: Up to 24-weeks ]
  • Physical Function [ Time Frame: Up to 24-weeks ]

Central Contacts and Locations

Central contacts

Noah Greenspan, DPT

(212) 249-0904consult@covidpt.org

Julie Walsh-Messinger, Ph.D.

(937) 229-1380udcovidstudy@udayton.edu

Locations

Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy

Recruiting

New York, New York, United States, 10017

Contacts

Noah Greenspan, DPT

212-921-0214consult@covidpt.org

Julie Walsh-Messinger, PhD

(937) 229-1380udcovidstudy@udayton.edu

Principal Investigator:

Noah Greenspan, DPT, CCS

More Information

Sponsor

Noah Greenspan

Last update posted

May 25, 2021

Last verified

May, 2021

Keywords

  • Post-COVID Syndrome
  • Post-acute COVID
  • Long COVID

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Noah Greenspan on 2021-05-25.