Exercise Therapy in Cancer Patients Hospitalized for COVID-19: A Digitized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 14
- 主要终点
- Frequency of serious adverse events during study-related assessments
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic exercise therapy program in cancer patients recovering from COVID-19. The study will look at whether the aerobic exercise therapy causes few or mild side effects in participants. Aerobic exercise is physical activity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for several minutes at a time. The aerobic exercise therapy being used in this study will be a walking program that will be adjusted so it matches participant fitness levels (how much exercise you can handle).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Previously admitted to a hospital for Covid-19
- •Discharged from hospital for at least 30 days
- •Previously treated for cancer at MSK
- •Interval of ≥ 12 months but ≤ 10 years following completion of primary non-hormonal anti-cancer therapy (current endocrine therapy and maintenance therapy allowed)
- •Space to house a treadmill at personal residence
- •Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+)
- •Performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self-report
- •If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
- •Women <50 years old who are of child-bearing potential must have a negative pregnancy test within 14 days of enrollment.
排除标准
- •Currently receiving home oxygen after discharge
- •Enrollment onto any other interventional investigational study
- •Current treatment for any other diagnosis of invasive cancer of any kind
- •Distant metastatic malignancy of any kind
- •Receiving non-hormonal anticancer therapy
- •Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
结局指标
主要结局
Frequency of serious adverse events during study-related assessments
时间窗: 30 weeks
Safety will be evaluated by the frequency of serious (i.e., life-threatening, hospitalization, significant incapacity, important medical events) adverse events during study-related assessments and exercise sessions according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
未报告次要终点