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临床试验/NCT04080414
NCT04080414已完成不适用

Home-based High-intensity Interval Training to Improve Colorectal Cancer Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of Colorectal Cancer Recurrence

University of Utah4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
4
主要终点
Feasibility of home-based high-intensity interval training among colorectal cancer survivors

研究概览

简要总结

This 12-week, exercise study will assess the feasibility of a home-based high-intensity interval training (HIIT) program among colorectal cancer survivors and explore the impact of home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic exercise program on physical outcomes linked with survival from colorectal cancer and surrogate blood markers of colorectal cancer recurrence.

HIIT is a type of aerobic exercise that includes short bursts (i.e. 1-4 minutes) of vigorous exercise followed by longer periods of moderate to lower intensity exercise (i.e. 1-10 minutes). Participants in this study will be randomly assigned into a personalized home based exercise program - either high-intensity interval training (HIIT) or moderate-intensity continuous aerobic exercise (MICE).

This pilot study will provide us with preliminary evidence for a larger trial aimed to compare the effectiveness of these two different types of home-based exercise programs on physical outcomes linked with survival, quality of life, and surrogate blood markers of colorectal cancer recurrence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are no more than five years post resection and/or adjuvant therapy for stage II-III Colorectal cancer (CRC).
  • Age 19-75 years old.
  • Engaging in less than 90 minutes per week of structured moderate- or vigorous-intensity aerobic exercise in the past three months
  • No known cardiovascular, metabolic or renal disease, and no signs/symptoms suggestive of cardiovascular, metabolic, or renal disease.
  • Must be able to read, speak and understand English
  • Willing to complete two assessment sessions (at baseline and 12 weeks).
  • Willing to engage in moderate- or vigorous-intensity aerobic exercise at home and use mobile health technology to track exercise adherence to the exercise prescription.
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  • Have regular access to a smart phone and willing to download a free application for device tracking

排除标准

  • Functional limitations requiring a walker, scooter, or wheelchair.
  • Clinically evident recurrent disease.
  • Resting blood pressure ≥140/90 at the time of baseline testing.
  • No access to smart phone and/or not willing download the device app

结局指标

主要结局

Feasibility of home-based high-intensity interval training among colorectal cancer survivors

时间窗: 12 weeks

Feasibility will be assessed by adherence to the home-based high-intensity interval training protocol, which is defined at the participant level as completing ≥70% of workouts consistent with the exercise prescription. The intervention will be considered feasible if ≥75% of participants meet or exceed the 70% criterion.

次要结局

未报告次要终点

研究者

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

Adriana Coletta

Assistant Professor

University of Utah

研究点 (4)

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