"SurgeryStrong". Preoperative Strength Exercise and Nutrition Program in Patients Completing Neoadjuvant Chemoradiation Therapy for Pancreatic and Gastric Cancer: A Randomized Trial Testing Effects on Strength, Fitness, Health-Related Quality of Life, and Perioperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in dynamic lower muscle strength
研究概览
简要总结
This clinical trial studies the effectiveness of a home-based exercise and nutrition monitoring program called Pt Pal in improving strength in patients with pancreatic or stomach cancer receiving chemoradiation therapy before surgery. Pt Pal is a mobile health technology used to facilitate communication between the care team and the patient/caregiver, by allowing the care team to send from their web-portal, exercise routines, activities of daily living, diet recommendations, surveys and educational material to the patient/caregiver's mobile device. The Pt Pal application (app) then captures the patient/caregiver activity adherence data and reports those results back to the care team. The Pt Pal program may help improve overall strength in patients undergoing surgery for pancreatic and stomach cancer relative to standard care.
详细描述
PRIMARY OBJECTIVE:
I. In patients with pancreatic and gastric cancer undergoing preoperative chemoradiation and potentially curative resection, compare the change in dynamic lower muscle strength as measured by the 1 repetition maximum (1-RM) leg press between the time of enrollment and prior to resection in those who: a. Are offered aerobic exercise encouragement prior to surgery b. Are offered aerobic exercise encouragement, nutrition monitoring, and a structured strength exercise program prior to surgery.
SECONDARY OBJECTIVES:
I. To compare the change in dynamic muscle strength as measured by the 1-RM for the chest press, seated row, and leg extension.
II. To compare upper and lower body muscle endurance as defined by the maximal number of repetitions performed at 70% of the pre-exercise 1-RM for the chest and leg press.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pancreatic or gastric adenocarcinoma, biopsy-proven
- •Have completed or are within 2 weeks of completion of preoperative chemoradiotherapy either on- or off-protocol
- •Anticipated to undergo potentially curative resection in 4-6 weeks from enrollment
- •Able to understand the description of the study and willing to participate
- •Able to understand the exercise program
- •Able to independently maintain daily exercise logs via Pt Pal -iOS, Android or desktop web browser on their own personal device
- •Telephone or email access and agreement to engage with the research personnel via phone or email
- •Meet all screening requirements, including physician clearance
- •>= age 18
排除标准
- •Non-English speaking
- •Has participated in moderate to high intensity strengthening exercises at least two times per week within the past four weeks prior to enrollment
- •Unable to complete the baseline assessment questionnaires or functional assessments
- •Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
- •Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
- •Numeric pain rating scale of >= 7 out of 10
- •Myopathic or rheumatologic disease that impacts physical function
- •Recurrent cancer following prior resection
- •< age 18
结局指标
主要结局
Change in dynamic lower muscle strength
时间窗: through study completion, an average of a year
次要结局
未报告次要终点