E-PROOF: E-Intervention for Protein Intake and Resistance Training to Optimize Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Physical Function at End-of-intervention
研究概览
简要总结
This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance training randomized trial with 70 older cancer survivors.
II. Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with the intervention participants.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 65 years of age
- •A primary diagnosis of stage I-III breast, colorectal, and prostate cancer
- •Completion of primary curative treatment
- •Reported at least 1 physical function limitation on the RAND-36 Physical Function Subscale (PFSS) ("limited a little", "limited a lot")
- •No evidence of progressive disease or second cancers
- •Community-dwelling
- •Able to provide consent
排除标准
- •Currently receive cancer treatment (e.g., chemotherapy, radiation)
- •Have liver and/or renal disease limiting their protein intake
- •Are under the care of a Registered Dietician (RD)/nutritionist
- •Participating in other diet/exercise interventions
- •Consume protein supplements
- •Have contraindications to unsupervised exercise (e.g., walker/wheelchair use)
结局指标
主要结局
Physical Function at End-of-intervention
时间窗: end-of-intervention, at 12 weeks
Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention.
次要结局
- Grip Strength(end-of-intervention, at 12 weeks)
- Anthropometry Measuring Waist Circumference in Centimeters(end-of-intervention, at 12 weeks)
- Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions(end-of-intervention, at 12 weeks)
- Study Accrual Rate(assessed during the 12 month recruitment period)
- Study Retention Rate(End-of-study, up to 3 months)
- Study Adherence Rate(end-of-intervention, at 12 weeks)
- Dietary Quality(end-of-intervention, at 12 weeks)
- Percentage of Participants Who Completed Resistance Exercises(end-of-intervention, at 12 weeks)
- Health-related Quality of Life (HRQoL)(end-of-intervention, at 12 weeks)
- Anthropometry Body Weight in Kilograms(end-of-intervention, at 12 weeks)
- Self-efficacy(end-of-intervention, at 12 weeks)
- Technology Competency(end-of-intervention, at 12 weeks)
- Anthropometry Height in Inches(end-of-intervention, at 12 weeks)
研究者
Jessica Krok-Schoen
Principal Investigator
Ohio State University Comprehensive Cancer Center