IIT2019-14-SHIRAZIP-SWEAT: Streaming Web-based Exercise At Home: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
This is a single-arm pilot study to evaluate the use of web-based video conferencing as a method of exercise training delivery. This study will include 10 female breast cancer survivors and 10 male prostate cancer survivors. For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male previously diagnosed with prostate cancer or female previously diagnosed with breast cancer.
- •For breast cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable.
- •For prostate cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for androgen receptor-targeted therapies (such as enzalutamide, apalutamide, darolutamide, or abiraterone). Patients currently on active surveillance are eligible even if they have not received prior anti-cancer treatment.
- •Has access to tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across.
- •Physically able to complete modified Bruce submaximal treadmill test, leg strength test, grip strength test, and InBody per patient self-assessment.
- •Physician clearance to participate in this study. Can be done through review of patients' medical records.
- •Ability to read, write, and understand English.
- •Has a chair at home to use for exercise that is not on wheels and has a solid back (not a reclining chair).
- •Ambulatory without assistance.
- •Has a clear 5 x 6-foot space at home in which to exercise.
- •Age >18 years.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Active treatment planned within the next 6 months. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for AR-targeted therapies for prostate cancer.
- •Known metastatic disease.
- •Grade 3 or higher peripheral neuropathy.
- •Major surgery within 3 months of baseline visit.
- •Positive pregnancy test for women of child-bearing potential.
- •Answers yes to any question on the Physical Activity Readiness Questionnaire unless study participation is cleared by a physician.
- •Known allergy to Fitbit device.
- •Currently meeting physical activity guidelines (score of >23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire).
研究组 & 干预措施
Exercise
For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Adherence
时间窗: 12 weeks
Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)
Attendance
时间窗: 12 weeks
Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)
Manipulation check
时间窗: 12 weeks
Explore adherence to intervention delivery measured through scores on manipulation check after each session (2 questions asked by exercise physiologist on sound and visual clarity of the session)
Patient consent
时间窗: 1 day
Explore adherence to intervention delivery measured through percentage of patients approached who sign consent
次要结局
- Changes in strength test (mid-study visit - end of study visit)(12 weeks)
- Changes in resting heart rate (baseline - end of study visit)(24 weeks)
- Changes in strength test (baseline - mid-study visit)(12 weeks)
- Changes in oxygen uptake (mid-study visit - end of study visit)(12 weeks)
- Changes in resting heart rate (mid-study visit - end of study visit)(12 weeks)
- Changes in body composition (mid-study visit - end of study visit)(12 weeks)
- Changes in body composition (baseline - end of study visit)(24 weeks)
- Changes in oxygen uptake (baseline - mid-study visit)(12 weeks)
- Changes in oxygen uptake (baseline - end of study visit)(24 weeks)
- Changes in body composition (baseline - mid-study visit)(12 weeks)
- Subjective impact(24 weeks)
- Changes in strength test (baseline - end of study visit)(24 weeks)
- Changes in resting heart rate (baseline - mid-study visit)(12 weeks)
研究者
Celina Shirazipour
Assistant Professor
Cedars-Sinai Medical Center