Enhanced External Counterpulsation to Treat Long COVID-19 Fatigue (EXPECT)

November 27, 2023 updated by: Prof. Dafna Yahav, Sheba Medical Center

Enhanced External Counterpulsation (EECP/ECPT) to Treat Long-COVID-19 Fatigue - a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced external counterpulsation
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
15 one-hour sessions during 15 weeks of enhanced external counterpulsation.
Sham Comparator: Sham procedure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fatigue score
Time Frame: 15 weeks
Change in PROMIS Fatigue 7a T score from baseline. Minimum score is 29, maximum 83, higher levels indicate worse outcome
15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in six-minute walk test
Time Frame: 15 weeks
Six-minute walk distance improvement in meters
15 weeks
Cahnge in endothelial function
Time Frame: 15 weeks
Endothelial dysfunction improvement by EndoPat test
15 weeks
Change in quality of life score
Time Frame: 15 weeks
Quality of life improvement per SF-36. Minimum value - 0 and maximum - 100, higher levels indicate worse outcome
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Dana Yelin, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 24, 2022

First Submitted That Met QC Criteria

December 24, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EECP for long COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared by approaching the PI, with reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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