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临床试验/NCT03953326
NCT03953326终止1 期

Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors

Penn State University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年4月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
3
试验地点
1
主要终点
Physical activity volume

研究概览

简要总结

This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • Diagnosis of breast cancer, leukemia, or lymphoma <15 yrs
  • Completed chemotherapy with cardiotoxic anthracycline-based agents 1+ year ago
  • English-proficiency
  • Own & use smartphone with Android operating system
  • Main Study and Ancillary Study

排除标准

  • Currently receiving curative treatment for cancer
  • 90+ min/week moderate (or greater) intensity PA
  • Any medical contraindications on the Physical Activity Readiness Questionnaire
  • Require an assistive device for mobility or has any other condition that may limit or prevent participation in moderate-intensity physical activity
  • Current smoker
  • Pregnant or planning to become pregnant in the next 6 mos/breastfeeding
  • Allergy to test substances
  • Allergy to latex
  • Ancillary Study:
  • Taking metformin
  • Current medications that could conceivably alter the cardiovascular or thermoregulatory control or responses (e.g. beta blockers, calcium channel blockers, angiotensin receptor blockers)

研究组 & 干预措施

HeartPhone Intervention

Experimental

Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity.

干预措施: HeartPhone app (Behavioral)

HeartPhone Intervention

Experimental

Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity.

干预措施: Acetylcholine (Drug)

HeartPhone Intervention

Experimental

Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity.

干预措施: Sodium Nitroprusside (Drug)

HeartPhone Intervention

Experimental

Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity.

干预措施: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester (Drug)

结局指标

主要结局

Physical activity volume

时间窗: 3 month

Daily step counts over 1-week from Fitbit device

次要结局

  • Microvessel function(3 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David E Conroy

Professor

Penn State University

研究点 (1)

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