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

NCT07492953 | Completed

• 4 other identifiers: TSGHIRB No. C202205103NSTC-114-2221-E-016-002-MY2MND-MAB-D-115223TSGH-E-115276
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Long COVID Symptoms

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake (Peak VO₂)

  Peak oxygen uptake was measured during symptom-limited cardiopulmonary exercise testing (CPET) performed on a cycle ergometer using a ramp protocol (0 W initial workload with increments of 10-15 W per minute). Breath-by-breath gas exchange was continuously recorded using a metabolic cart. Peak VO₂ was defined as the highest 30-second averaged oxygen uptake during the test and expressed in mL·kg-¹·min-¹. Continuous ECG and pulse oximetry monitoring were performed during the test. Exercise was terminated at volitional fatigue or standardized safety criteria.

  Baseline and within 1 week after completion of the 35-hour EECP intervention (approximately 4-7 weeks).

Secondary Outcomes (9)

• The Six-Minute Walk Test (6MWT)

  Baseline and again within one week after completing EECP

• Blood Pressure and Heart Rate

  Baseline and weekly, immediately before and after each EECP session, throughout the treatment period.

• PROMIS Physical Health score

  Baseline and within 1 week after completion of the intervention

• PROMIS Mental Health Score

  Baseline and within 1 week after completion of the intervention

• PROMIS Sleep Disturbance Domain

  Baseline and within 1 week after completion of the intervention

Study Arms (2)

Standard EECP Group (1-hour sessions)

EXPERIMENTAL

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.

Device: enhanced external counterpulsation

Accelerated EECP Group (2-hour sessions)

EXPERIMENTAL

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.

Device: enhanced external counterpulsation

Interventions

enhanced external counterpulsation DEVICE

Participants receive enhanced external counterpulsation (EECP) therapy achieving the same total treatment dose of 35 hours.

Accelerated EECP Group (2-hour sessions); Standard EECP Group (1-hour sessions)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Natioanl Denfense Medical University

Taipei, 114, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, College of Public Health, National Defense Medical University, Taipei, Taiwan

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 25, 2026
• Study Start: December 25, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: March 25, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)