An interventional study of Enhanced external counterpulsation in Post-Acute COVID-19 Syndrome, sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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:
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:
Questionnaire that will be used before and after the intervention will include:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 32 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enhanced external counterpulsation (EECP/ECPT) is a non-invasive technique used to improve cardiac and cerebral perfusion. It aims to achieve 'diastolic augmentation' by increasing arterial blood pressure and retrograde aortic blood flow during diastole. This technique is currently used to treat refractory angina and heart failure, and was demonstrated to be well tolerated without limiting side effect. Practially, blood pressure cuffs are put along the lower limbs and are inflated to 300 mmHg pressure intermittently during one hour session. 15 sessions will be performed over 15 weeks.
Procedure: Enhanced external counterpulsation
The procedure will be identical to the experimental procedure, excluding the pressure that will reach only 80 mmHg.
Procedure: Enhanced external counterpulsation
15 one-hour sessions during 15 weeks of enhanced external counterpulsation.
Change in fatigue score
Change in PROMIS Fatigue 7a T score from baseline. Minimum score is 29, maximum 83, higher levels indicate worse outcome
Time frame: 15 weeks
Change in quality of life score
Quality of life improvement per SF-36. Minimum value - 0 and maximum - 100, higher levels indicate worse outcome
Time frame: 15 weeks
Change in six-minute walk test
Six-minute walk distance improvement in meters
Time frame: 15 weeks
Cahnge in endothelial function
Endothelial dysfunction improvement by EndoPat test
Time frame: 15 weeks
Plan to share: Yes — Data will be shared by approaching the PI, with reasonable request
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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