enhanced external counterpulsation to treat long covid-19 fatigue

Conditions: Post-Acute COVID-19 Syndrome

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 score * whether 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.

participants of this trial will be patients recovering from acute covid-19, 3-12 months following the acute infection, and suffering from fatigue with a patient-reported outcomes measurement system (promis)-fatigue short-form (sf)-7a score of \> 50. exclusion criteria will include contra-indications for eecp (see protocl). intervention, comparisn and outcomes are described above. study plan: participants will be invited using social media, after filling a fatigue score (promis) to test for eligibility. those with a score of \> 50 will be invited for a study visit. study visit 1 will include informed consent, followed by physician interview, physical examination, ecg; and will be referred for completion of blood tests including complete blood count (cbc) to rule out significant anemia (hb\< 12 for men or hb \<10 for women) and serum beta human chorionic gonadotrophin (bhcg). eligible patients will then be randomized into two groups for treatment with eecp vs sham procedure. in study visit 2 they will answer several questionnaires, perforn endopat test to assess endothelial dysfunction, and six-minute walk test, followed by either: 1. treatment group- 1 hour eecp session 2. sham group - 1 hour of a sham eecp session (patients will be hooked to the eecp device but it will be set to the lowest setting, and lowest frequency, therefore unable to create a sufficient rise in diastolic return). this visit will be followed by 3 times weekly 1 hour sessions for 5 weeks (15 sessions) of either eecp or sham procdeure, according to randomization group. questionnaire that will be used before and after the intervention will include: 1. fatigue evaluation using the promis 7a form, attached in appendix (as validated on myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs)patients) 2. functional capacity evaluation using the duke activity status assessment (dasi) (https://www.mdcalc.com/duke-activity-status-index-dasi); 3. shortness of breath using the modified medical research council dyspnea scale 4. quality of life using the sf-36 questionnaire. 6mwt and endothelial dysfunction by endopat will be held following the last treatment. study visit 3 (3 months following starting treatment) will be a final interview to assess improvement by questionnaires, as well as time to return to activity and time to return to work.

Eligibility criteria:
inclusion criteria: * patients recovering from pcr or lateral flow testing proven acute covid-19 * 3-12 months following the acute infection * suffering from fatigue with a promis-sf-7a t-score of \> 50 exclusion criteria: * acute decompensated heart failure * recent myocardial infarction within the last 3 months * unstable angina pectoris * severe hypertension \> 180/110 mm hg * coagulopathy with international normalized ratio of prothrombin time \> 2.0 * moderate to severe aortic regurgitation * abdominal aortic aneurysm (\>5 mm) or dissection * arrhythmias that may interfere with triggering of eecp system (uncontrolled atrial fibrillation, flutter and very frequent premature ventricular contractions) * heart rate of \ 125 beats per minute * any surgical intervention within 6 weeks before eecp * recent cardiac catheterization (1-2 weeks) or arterial femoral puncture * severe peripheral arterial disease * severe venous disease (thrombophlebitis, prior or current deep vein thrombosis or pulmonary embolism) * severe chronic obstructive pulmonary disease * pregnancy or women of childbearing age who do not have a negative pregnancy test

Keywords: long covid enhanced external counterpulsation