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| ID | Type | Description | Link |
|---|---|---|---|
| NSTC-114-2221-E-016-002-MY2 | Other Grant/Funding Number | National Science and Technology Council | |
| MND-MAB-D-115223 | Other Grant/Funding Number | Medical Affairs Bureau, Ministry of National Defense | |
| TSGH-E-115276 | Other Grant/Funding Number | Tri-Service General Hospital |
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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:
Researchers will compare two EECP treatment schedules to determine whether a shorter, accelerated program provides similar benefits to the standard schedule.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enhanced external counterpulsation | Device | Participants receive enhanced external counterpulsation (EECP) therapy achieving the same total treatment dose of 35 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Natioanl Denfense Medical University | Taipei | 114 | Taiwan |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and within 1 week after completion of the intervention |