Enhanced External Counterpulsation (EECP/ECPT) to Treat Long-COVID-19 Fatigue - a Randomized Controlled Trial
Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Israel
Sheba medical center
RECRUITING
Ramat Gan
Contact Information
Primary
Dafna Yahav, MD
Dafna.Yahav@sheba.health.gov.il
972548866488
Backup
Dana Yelin, MD
Dana.Yelin@sheba.health.gov.il
972545383536
Time Frame
Start Date: 2023-04-01
Completion Date: 2024-07
Participants
Target number of participants: 32
Treatments
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.
Sham_comparator: Sham procedure
The procedure will be identical to the experimental procedure, excluding the pressure that will reach only 80 mmHg.
Related Therapeutic Areas
Sponsors
Leads: Sheba Medical Center