RECRUITING

A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Participants will be asked to undergo Cardiopulmonary Exercise Testing (CPET) before and after 12-weeks of training via one of the 4 modalities (random assignment) listed above. They will respond to questions regarding acceptability of the interventions.

Official Title

A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities

Quick Facts

Study Start:2025-04-06

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06931470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. \>45 years 2. 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) 3. 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 \<50mg/dL for women, \<40mg/dL for women, in addition to fasting triglycerides \>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: * Obesity: * 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.	1. Established diagnosis of atherosclerotic CVD 2. 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) 3. Pregnant or anticipating pregnancy 4. Plan to be away for \>2 weeks during the intervention period 5. Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation

Inclusion Criteria

Exclusion Criteria

1. \>45 years
2. 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)
3. 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 \<50mg/dL for women, \<40mg/dL for women, in addition to fasting triglycerides \>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:
* Obesity:
* 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.

1. Established diagnosis of atherosclerotic CVD
2. 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)
3. Pregnant or anticipating pregnancy
4. Plan to be away for \>2 weeks during the intervention period
5. Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation

Contacts and Locations

Study Contact

Alec Sinatro, MD

CONTACT

914-571-9575

alec.sinatro@nyulangone.org

Sean Heffron, MD

CONTACT

857-366-1417

Sean.heffron@nyulangone.org

Principal Investigator

Sean P. Heffron, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Sean P. Heffron, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-06

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-04-06

Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

Cardiovascular Diseases