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New treatment option for Cardiovascular Diseases
Official title A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
ClinicalTrials.gov ID: NCT06931470
What this study is testing
- What it's testing
- This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical activity. The study aims to 1) Assess the effect of several approaches to remote aerobic training on measures of physical activity, cardiovascular fitness and CVD risk, and 2) Quantitatively and qualitatively evaluate exercise training program fidelity, implementation, effectiveness, and remaining barriers to acceptance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- \>45 years
- At risk for CVD (participants must have one or more of the following risk factors: hypertension, hyperlipidemia, Type 2 Diabetes Mellitus, smoking...
- Not meeting AHA physical activity guidelines for at least 3 months prior to screening
- Hypertension:
- Systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg and/or
You likely can't join if
- Established diagnosis of atherosclerotic CVD
- Presence of any serious medical conditions that would not allow safe participation in exercise according to the American College of Sports Medicine...
- Pregnant or anticipating pregnancy
- Plan to be away for \>2 weeks during the intervention period
- Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study...
See the full eligibility criteria
- \>45 years
- At risk for CVD (participants must have one or more of the following risk factors: hypertension, hyperlipidemia, Type 2 Diabetes Mellitus, smoking, obesity, family history of premature CVD)
- Not meeting AHA physical activity guidelines for at least 3 months prior to screening
- Hypertension:
- Systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg and/or
- Use of anti-hypertensive medication
- Hyper / dyslipidemia
- LDL cholesterol levels ≥160 mg/dL and/or
- HDL cholesterol \ 150mg/dL
- Diabetes Mellitus:
- Hemoglobin A1c levels ≥6.5%, fasting glucose levels ≥126 mg/dL, or 2-hour glucose levels ≥200 mg/dL after an oral glucose tolerance test and/or
- Use of any diabetes medication
- Smoking: o Current regular tobacco use.
- Obesity: o BMI ≥30 kg/m².
- Family History of Premature Cardiovascular Disease:
- Having a first-degree relative (parent, sibling) who developed CVD before age 55 for biological males or age 65 for biological females.
- Established diagnosis of atherosclerotic CVD
- Presence of any serious medical conditions that would not allow safe participation in exercise according to the American College of Sports Medicine (ACSM) and the AHA (56-58)
- Pregnant or anticipating pregnancy
- Plan to be away for \>2 weeks during the intervention period
- Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.