Clinical trial NCT04898205: Cardiopulmonary Rehabilitation in COVID-19 Longhaulers
Official title: Cardiopulmonary Rehabilitation in COVID-19 Longhaulers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Viral Syndrome
Keywords: Post-COVID Syndrome
Post-acute COVID
Long COVID
Lead sponsor: Pulmonary Wellness Foundation
Sponsor class: OTHER
Collaborators: name: University of Dayton
First posted: 2021-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study entails 24 treatment sessions. The first 8 sessions involve four experimental conditions: 1) exercise + oxygen (treatment), exercise + air (active control), oxygen only (active control), air only (placebo). Pre-treatment testing will then be repeated, after which all participants will crossover to 16 sessions of exercise + oxygen.
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Heart rate and rhythm response to exercise and positional changes
timeFrame: Up to 24-weeks
measure: Blood pressure response to exercise and positional changes
timeFrame: Up to 24-weeks
measure: Activity metabolic equivalent of task (MET) tolerated
timeFrame: Up to 24-weeks
measure: Breathlessness
timeFrame: Up to 24-weeks
measure: Rate of perceived exertion (RPE)
timeFrame: Up to 24-weeks
measure: Cognition (attention, short, delayed, and working memory, verbal fluency, and abstraction).
timeFrame: Up to 24-weeks
measure: Post-acute COVID symptoms (PACS)
timeFrame: Up to 24-weeks
measure: Physical Function
timeFrame: Up to 24-weeks
Secondary outcomes:
measure: Depression
timeFrame: Up to 24-weeks
measure: Generalized anxiety
timeFrame: Up to 24-weeks
measure: State anxiety
timeFrame: Up to 24-weeks
measure: Trait anxiety
timeFrame: Up to 24-weeks
measure: Improvement in quality of life
timeFrame: Up to 24-weeks
measure: Perception of cognitive function
timeFrame: Up to 24-weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Post-COVID Rehabilitation and Recovery Clinic at H&D Physical Therapy
state: New York
Study officials:
affiliation: Pulmonary Wellness Foundation
name: Noah Greenspan, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dayton
name: Julie Walsh-Messinger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: