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| Column | Value |
|---|---|
| Trial registration number | NCT05668039 |
|
Full text link
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Dafna.Yahav@sheba.health.gov.il |
|
Registration date
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
2022-12-29 |
|
Recruitment status
Last imported at : Dec. 1, 2023, 8 a.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Dec. 1, 2023, 8 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: 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 |
|
Exclusion criteria
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
acute decompensated heart failure recent myocardial infarction within the last 3 months unstable angina pectoris severe hypertension > 180/110 mm hg coagulopathy with international normalized ratio of prothrombin time > 2.0 moderate to severe aortic regurgitation abdominal aortic aneurysm (>5 mm) or dissection arrhythmias that may interfere with triggering of eecp system (uncontrolled atrial fibrillation, flutter and very frequent premature ventricular contractions) heart rate of <35 or >125 beats per minute any surgical intervention within 6 weeks before eecp recent cardiac catheterization (1-2 weeks) or arterial femoral puncture severe peripheral arterial disease severe venous disease (thrombophlebitis, prior or current deep vein thrombosis or pulmonary embolism) severe chronic obstructive pulmonary disease pregnancy or women of childbearing age who do not have a negative pregnancy test |
|
Number of arms
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Sheba Medical Center |
|
Inclusion age min
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Dec. 1, 2023, 8 a.m. Source : ClinicalTrials.gov |
Israel |
|
Type of patients
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
32 |
|
primary outcome
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Change in fatigue score |
|
Notes
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Jan. 2, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2673, "treatment_name": "Enhanced external counterpulsation", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |