Using Enhanced External Counterpulsation to Recover Cardiovascular Function for Patient of Chronic Diseases

National Defense Medical Center, Taiwan

Status: Completed

Conditions: Long COVID Symptoms

Treatments: Device: enhanced external counterpulsation

Study type: Interventional

Funder types: Other

Identifiers

NCT07492953

TSGHIRB No. C202205103

MND-MAB-D-115223 (Other Grant/Funding Number)

TSGH-E-115276 (Other Grant/Funding Number)

NSTC-114-2221-E-016-002-MY2 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this clinical trial is to learn whether enhanced external counterpulsation (EECP) therapy can improve cardiopulmonary function and symptoms in adults with long COVID. It will also evaluate the safety and feasibility of two different EECP treatment schedules.

The main questions it aims to answer are:

• Does EECP therapy improve functional exercise capacity and cardiopulmonary performance in patients with long COVID?
• Do different EECP treatment schedules (standard vs. accelerated sessions) lead to different improvements in symptoms, quality of life, and physiological outcomes?
• What side effects or medical problems occur during EECP therapy?

Researchers will compare two EECP treatment schedules to determine whether a shorter, accelerated program provides similar benefits to the standard schedule.

Participants will:

• Receive EECP therapy either 1 hour per day (5 days per week for 7 weeks) or 2 hours per day (5 days per week for about 4 weeks), both totaling 35 hours of treatment
• Visit the cardiopulmonary rehabilitation clinic regularly for supervised treatment sessions
• Complete physical performance tests (such as the Six-Minute Walk Test and cardiopulmonary exercise testing)
• Have blood pressure and heart rate measured
• Complete questionnaires about symptoms, physical function, sleep quality, and quality of life

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 20 years
• Eligible for follow-up ≥3 months
• A confirmed history of COVID-19 (via PCR or antigen test)
• Post-COVID-19 with persistent symptoms ( fatigue, exercise intolerance, dyspnea on exertion, and/or cognitive difficulties) for ≥3 months

Exclusion criteria

• Severe peripheral arterial disease or limb ischemia
• Active deep vein thrombosis
• Aortic valve regurgitation,
• Aortic aneurysm requiring surgical repair
• Pregnancy
• Other serious cardiovascular conditions contraindicating EECP
• Unable to ambulate
• Severe neurocognitive impairment precluding consent or cooperation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Standard EECP Group (1-hour sessions)

Experimental group

Description:

Participants receive enhanced external counterpulsation (EECP) therapy for 1 hour per session, 5 days per week for 7 weeks, targeting a total treatment dose of 35 hours. EECP is delivered using pneumatic cuffs wrapped around the calves, thighs, and buttocks, with inflation synchronized to the cardiac cycle. Sessions are supervised by rehabilitation staff.

Treatment:

Device: enhanced external counterpulsation

Accelerated EECP Group (2-hour sessions)

Experimental group

Description:

Participants receive enhanced external counterpulsation (EECP) therapy for 2 hours per session, 5 days per week for approximately 4 weeks, achieving the same total treatment dose of 35 hours. The 2-hour treatment may be delivered as a continuous session or two consecutive 1-hour sessions based on patient tolerance. Sessions are supervised by rehabilitation staff.

Treatment:

Device: enhanced external counterpulsation