Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT04603157
Eligibility Criteria:
Inclusion Criteria:
* Must be 18 years old or older
* Meet diagnosis criteria for POTS = a heart rate increase of ≥ 30bpm with supine to 10 minutes of standing or head-up tilt or heart rate exceeding 120 ppm after 10 minutes of standing or tilt without evidence of orthostatic hypertension (a fall in BP of \> 20/10 mmHg)
* Been diagnosed with POTS ≥6 months prior to participation in the study (chronic)
* Female subjects must not be pregnant or trying to become pregnant during duration of study participation
* Those in exercise training group must be on stable medications for at least 1 month and medication must remain consistent for duration of study participation. For those in the standard of care group, a change in medication will be allowed within the first month following baseline testing, but then must remain consistent until 3-month testing time point.
* Ehlers-Danlos Syndrome (EDS) patients will be included, but will target equal randomization between treatment groups
Exclusion Criteria:
* Individual is not eligible if they are currently exercising, cut off \>30 minutes of structured exercise/physical activity per week. (assessed by Global Physical Activity Questionnaire)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04603157
Study Brief:
Protocol Section:
NCT04603157