COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04595773

COVID-CARE Rehab Team

covidcarerehabteam@nih.gov

2020-10-22

Recruiting

RCT

Randomized

Crossover

Blind label

single-center

Long covid

inclusion criteria: screening procedures will be performed as part of this study. in order to be eligible to participate in this study, an individual must meet all of the following criteria: male or female, aged 18 to 80 years previous infection with sars-cov2 at least 4 weeks prior to enrollment, confirmed by laboratory or a healthcare provider. participants with a documented positive home antigen test will need confirmation of positive covid-19 antibodies (positive anti-nucleocapsid antibody test, or positive anti-spike antibody test if unvaccinated at the time of the antibody test) to be considered. presence of physical limitations or significant fatigue since covid-19 as demonstrated by: total score <= 19 on the promis short form for physical function or total score >= 9 on the promis short form for fatigue, and score >= 1 on the patient global rating of flu severity and patient global assessment of interference with daily activities absence of post-exertional malaise (pem) as identified on the dsq-pem where: items 1 to 5 has no score >= 2 for frequency and no score >= 2 for severity, occurring in the same row, and item 7 or 8 is no , and item 9 is <= 13 hours able to read, speak and understand english or spanish able to understand and willing to sign a written informed consent document willing and able to complete study procedures

an individual who meets any of the following criteria will be excluded from participation in this study: above normal performance (i.e, >=100% predicted) in the 6mwt based on normative data for gender and age history or cardiac condition as determined by nih cardiology to be unsafe for exercise participation (e.g. ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non-idiopathic cardiomyopathy) significant hepatic or renal dysfunction cancer diagnosis with evidence of metastasis or a life expectancy of less than one year history of stroke resulting in impairments in functional mobility that limits safe participation active substance abuse including etoh severe psychiatric disease, not responsive to treatment or medication history of diabetes and on insulin pump therapy, or uncontrolled diabetes with hba1c > 9.0% pregnancy acceptance onto a lung transplant waiting list extreme obesity with bmi > 40 kg/m2 on medications that would influence exercise performance such as beta blockers or antiretroviral therapy ongoing tobacco and/or nicotine product use enrolled in another interventional clinical research trial any other medical or health condition(s) that unduly increases the risk of exercise testing or training, affects the normal physiologic response to exercise testing or training, and/or would otherwise interfere with the ability to interpret the data as determined by the pi

2

National Institutes of Health Clinical Center (CC)

18

80

United States

Patients recovered from covid

N/A

90

6 minute walk test distance

None

Phase 1/Phase 2

[{"arm_notes": "nan", "treatment_id": 41, "treatment_name": "Aerobic exercise", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 961, "treatment_name": "Patient education", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]