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Not Yet Recruiting NCT05668039

Enhanced External Counterpulsation to Treat Long COVID-19 Fatigue

Conditions: Post-Acute COVID-19 Syndrome

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 32
Sponsor: Sheba Medical Center

Summary

The goal of this double blind, outcome-assessor blind, randomized controlled trial, is to compare the effectiveness of external encounter counterpulsation (EECP) versus sham procedure in participants with long COVID-19 fatigue.The main question[s] it aims to answer are:Whether EECP improves fatigue scoreWhether EECP improves quality of life, six-minute walk test, and endothelial function Participants will attend 15 sessions (1-hour each) of EECP during 5 weeks Researchers will compare EECP versus sham procedure for the above outcomes.

Eligibility Criteria

Inclusion Criteria:Patients recovering from PCR or lateral flow testing proven acute COVID-193-12 months following the acute infectionSuffering from fatigue with a PROMIS-SF-7a T-score of > 50Exclusion Criteria:Acute decompensated heart failureRecent myocardial infarction within the last 3 monthsUnstable angina pectorisSevere hypertension > 180/110 mm HgCoagulopathy with international normalized ratio of prothrombin time > 2.0Moderate to severe aortic regurgitationAbdominal aortic aneurysm (>5 mm) or dissectionArrhythmias that may interfere with triggering of EECP system (uncontrolled atrial fibrillation, flutter and very frequent premature ventricular contractions)Heart rate of <35 or >125 beats per minuteAny surgical intervention within 6 weeks before EECPRecent cardiac catheterization (1-2 weeks) or arterial femoral punctureSevere peripheral arterial diseaseSevere venous disease (thrombophlebitis, prior or current deep vein thrombosis or pulmonary embolism)Severe chronic obstructive pulmonary diseasePregnancy or women of childbearing age who do not have a negative pregnancy test

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05668039). StuddyBuddy aggregates publicly available trial information.