Evaluating Changes in Functional Fitness Following a 10-Week Home-Based Comprehensive Exercise Program in Endometrial Cancer Patients Who Have Completed Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Chair sit to stand test
研究概览
简要总结
This early phase I clinical trial measures the changes in functional fitness following home-based comprehensive exercise program in patients who have endometrial cancer who have completed treatment. Endometrial cancer is an increasingly common diagnosis, with health and quality of life concerns persisting after the active cancer treatment period. Exercise in cancer survivors has the potential to reduce the risk of death by improving cardiovascular fitness, quality of life, strength, longevity, and independence. A home-based exercise programs may be a feasible approach for exercise programming in patients who have endometrial cancer who have completed treatment.
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 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to provide written informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Fluent in spoken and written English
- •Women 18-74 years of age
- •Documented diagnosis of type I, stage I-IIIc endometrial cancer within the past 5 years
- •Completion of current treatment for endometrial cancer
- •Technology access (cellphone with data, broadband internet, WiFi) for tele coaching
- •Pass the Physical Activity Readiness Questionnaire (PAR-Q)
排除标准
- •Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations
- •Have evidence of recurrent or metastatic disease
- •Are currently performing resistance training >= 2 days per week
- •Are currently exceeding 150 minutes of at least moderate intensity activity per week
- •Report of chest pain, shortness of breath, fainting, or angina pectoris
- •Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block
- •Plans to move from the area
- •Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization
- •Women who are pregnant or breast-feeding
- •Not suitable for study participation due to other reasons at the discretion of the investigator
- •Failing the Physical Activity Readiness Questionnaire
结局指标
主要结局
Chair sit to stand test
时间窗: baseline, pre-intervention and immediately after the intervention
Will be assessed using the Functional Fitness Test, which is a battery of six tests including the 30 second chair stand, the 30 second arm curl, the 6-minute walk, the chair sit and reach, the 8-foot up and go, and the back scratch tests. Mixed effects regression models will be used to estimate changes in each of the 6 tests included in the Functional Fitness Test from pre- to post-intervention. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary outcome is number of repetitions in the chair sit to stand test
Chair sit to stand test
时间窗: baseline, pre-intervention and immediately after the intervention
Will be assessed using the Functional Fitness Test, which is a battery of six tests including the 30 second chair stand, the 30 second arm curl, the 6-minute walk, the chair sit and reach, the 8-foot up and go, and the back scratch tests. Mixed effects regression models will be used to estimate changes in each of the 6 tests included in the Functional Fitness Test from pre- to post-intervention. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary outcome is number of repetitions in the chair sit to stand test
次要结局
- Incidence of adverse events(Up to 10 weeks)
- Muscle strengthening exercise session adherence(Up to 10 weeks)
- Aerobic physical activity adherence(Up to 10 weeks)
- Tele coaching adherence(Up to 10 weeks)
- Exercise program acceptability(Up to 10 weeks)
- Body weight(baseline, pre-intervention and immediately after the intervention)
- Ambulatory activity levels(baseline, pre-intervention and immediately after the intervention)
- Incidence of adverse events(Up to 10 weeks)
- Muscle strengthening exercise session adherence(Up to 10 weeks)
- Aerobic physical activity adherence(Up to 10 weeks)
- Tele coaching adherence(Up to 10 weeks)
- Exercise program acceptability(Up to 10 weeks)
- Body weight(baseline, pre-intervention and immediately after the intervention)
- Ambulatory activity levels(baseline, pre-intervention and immediately after the intervention)
研究者
Jess S. Gorzelitz
Assistant Professor
University of Iowa