Long COVID SymptomsNCT07492953
Using Enhanced External Counterpulsation to Recover Cardiovascular Function for Patient of Chronic Diseases
A study testing enhanced external counterpulsation in people with Long COVID Symptoms, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long COVID Symptoms
- What is being tested?
- enhanced external counterpulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Dec 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Being tested
- enhanced external counterpulsation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced external counterpulsationDevice
Participants receive enhanced external counterpulsation (EECP) therapy achieving the same total treatment dose of 35 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: enhanced external counterpulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The Six-Minute Walk Test (6MWT) was used to assess aerobic capacity and endurance. Participants were instructed to walk at their maximal comfortable pace back-and-forth along a 30-meter corridor for 6 minutes, and the total distance walked (in meters) was recorded. One practice trial was done at baseline to familiarize patients, followed by a measured 6MWT at baseline and again within one week after completing EECP. Standard encouragement and stopping criteria were applied.
Measured: Baseline and again within one week after completing EECP
Blood Pressure and Heart Rate
Resting blood pressure (BP) (systolic and diastolic) and resting heart rate were measured after 5 minutes seated, at baseline and post-intervention. We also tracked any change in these vital signs immediately before and after individual EECP sessions to monitor acute effects. For analysis, we focused on the baseline vs post-intervention resting BP and HR changes.
Measured: Baseline and weekly, immediately before and after each EECP session, throughout the treatment period.
PROMIS Physical Health score
Physical health status was assessed using the PROMIS Adult Health Profile short form. The Physical Health domain includes items related to fatigue, pain, and physical functioning. Scores were calculated using a summed short-form scale ranging from 4 to 20, with higher scores indicating better physical health.
Measured: Baseline and within 1 week after completion of the intervention
PROMIS Mental Health Score
Mental health status was assessed using the PROMIS Adult Health Profile short form. The Mental Health domain includes items related to depression, anxiety, and social role functioning. Scores were calculated using a summed short-form scale ranging from 4 to 20, with higher scores indicating better mental health.
Measured: Baseline and within 1 week after completion of the intervention
PROMIS Sleep Disturbance Domain
Sleep disturbance was evaluated using the PROMIS Sleep Disturbance domain. This measure assesses perceived sleep quality and sleep-related problems, with higher scores indicating greater sleep disturbance.
Measured: Baseline and within 1 week after completion of the intervention
Seattle Angina Questionnaire-7 (SAQ-7) summary score
Cardiovascular health status was assessed using the Seattle Angina Questionnaire-7 (SAQ-7), a validated instrument evaluating angina frequency, physical limitation, and disease-specific quality of life related to coronary artery disease. Scores range from 0 to 100, with higher scores indicating fewer angina symptoms and better quality of life.
Measured: Baseline and within 1 week after completion of the intervention
COPD Assessment Test (CAT) score
Respiratory symptom burden was measured using the COPD Assessment Test (CAT), an 8-item questionnaire evaluating symptoms such as cough, dyspnea, chest tightness, and energy level. Total scores range from 0 to 40, with lower scores indicating fewer respiratory symptoms.
Measured: Baseline and within 1 week after completion of the intervention
Rose Dyspnea Scale (RDS)
Breathlessness severity was evaluated using the Rose Dyspnea Scale (RDS), a 4-item scale assessing dyspnea during physical activities. Scores range from 0 to 4, with higher grades indicating more severe dyspnea.
Measured: Baseline and within 1 week after completion of the intervention
Pittsburgh Sleep Quality Index (PSQI) global score
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire measuring sleep quality and disturbances over the previous month. The instrument includes seven components that generate a global score ranging from 0 to 21. Higher scores indicate worse sleep quality, and a global score greater than 5 indicates poor sleep quality.
Measured: Baseline and within 1 week after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start25 Dec 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Tien Chang, National Defense Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492953
- Sponsor's protocol ID
- TSGHIRB No. C202205103
- Other IDs
- NSTC-114-2221-E-016-002-MY2, MND-MAB-D-115223, TSGH-E-115276
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Enhanced External Counterpulsation to Recover Cardiovascular Function for Patient of Chronic Diseases
- ClinicalTrials.gov ID
- NCT07492953
- Acronym / sponsor ID
- TSGHIRB No. C202205103
- Conditions
- Long COVID Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard EECP Group (1-hour sessions) | Experimental | Device: enhanced external counterpulsationParticipants 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. |
| Accelerated EECP Group (2-hour sessions) | Experimental | Device: enhanced external counterpulsationParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Severe peripheral arterial disease or limb ischemia
- Active deep vein thrombosis
- Aortic valve regurgitation,
- Aortic aneurysm requiring surgical repair
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced external counterpulsationParticipants receive enhanced external counterpulsation (EECP) therapy achieving the same total treatment dose of 35 hours. | Device | Accelerated EECP Group (2-hour sessions), Standard EECP Group (1-hour sessions) |
Primary outcome
Peak oxygen uptake (Peak VO₂)
Time frame: Baseline and within 1 week after completion of the 35-hour EECP intervention (approximately 4-7 weeks).
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.
9 secondary outcomes
The Six-Minute Walk Test (6MWT)
Time frame: Baseline and again within one week after completing EECP
Blood Pressure and Heart Rate
Time frame: Baseline and weekly, immediately before and after each EECP session, throughout the treatment period.
PROMIS Physical Health score
Time frame: Baseline and within 1 week after completion of the intervention
PROMIS Mental Health Score
Time frame: Baseline and within 1 week after completion of the intervention
PROMIS Sleep Disturbance Domain
Time frame: Baseline and within 1 week after completion of the intervention
Seattle Angina Questionnaire-7 (SAQ-7) summary score
Time frame: Baseline and within 1 week after completion of the intervention
COPD Assessment Test (CAT) score
Time frame: Baseline and within 1 week after completion of the intervention
Rose Dyspnea Scale (RDS)
Time frame: Baseline and within 1 week after completion of the intervention
Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Baseline and within 1 week after completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced external counterpulsation in people with Long COVID Symptoms, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (Peak VO₂) (time frame: Baseline and within 1 week after completion of the 35-hour EECP intervention (approximately 4-7 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.