The goal of this double blind, outcome-assessor blind, randomized controlled trial, is tocompare the effectiveness of external encounter counterpulsation (EECP) versus shamprocedure 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.
Procedure: Enhanced external counterpulsation
15 one-hour sessions during 15 weeks of enhanced external counterpulsation.
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 <35 or >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
Sheba medical center
Ramat Gan, Israel
Investigator: Dana Yelin, MD
Dana.Yelin@sheba.health.gov.il
Dafna Yahav, MD
972548866488
Dafna.Yahav@sheba.health.gov.il
Dana Yelin, MD
972545383536
Dana.Yelin@sheba.health.gov.il
Dana Yelin, MD, Principal Investigator
Sheba Medical Center