Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in ankle dorsiflexion by arm
研究概览
简要总结
This study is being conducted because low lean muscle mass is prevalent among childhood cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the body's lean body mass. Low lean muscle mass is associated with loss of overall body strength, declining mobility and eventually, loss of independence. Among childhood cancer survivors, low lean muscle mass may contribute to reduced physical functioning and a sense of fatigue with exertion, limiting ability to participate in adequate physical activity. Loss of strength and a sense of fatigue with repeated movement make it difficult to participate in daily activities.
Although there have not been exercise intervention studies among childhood cancer survivors specifically designed to evaluate the effects of resistance training on muscle mass, studies among individuals with chronic disease, including survivors of adult onset cancers, indicate that resistance exercise improves muscle mass, muscle strength, mobility, vitality and physical activity levels. Resistance training (weight lifting) is a form of physical activity that is designed to improve muscular fitness by exercising a muscle or a muscle group against external resistance.
The purpose of the study is to evaluate the effects of resistance training combined with either a protein supplement or a sports drink on changes in lean muscle mass in young adults who were treated for childhood cancer. The sports drink, for this study, is considered a placebo.
详细描述
This double-blind placebo controlled study will randomize adult survivors of childhood cancer who are 18 to 44 years of age, greater than ten years post first cancer diagnosis, and with low lean muscle mass to two groups: Resistance Training + Supplement (RT+S) or Resistance Training + Placebo (RT+P). Randomization will be stratified by sex and age (18-29 and 30-44 years) in a block size of 4. Three weekly resistance training sessions will occur over a 24 week period. The participants, investigator, trainer and individuals involved in testing will be blind to group assignment.
Participants will receive information about physical activity and its health benefits. They will be randomly assigned to one of two groups to receive individually tailored resistance training three times per week for 24 weeks. One group will receive a protein supplement, while the other group will receive a sports drink (placebo).
To assess outcomes, participants will have the following research tests:
- Blood will be drawn to assess heart health.
- Questionnaires will be completed to assess physical activity and health as well as food intake.
- Blood pressure measurement.
- Electrocardiogram to assess heart health.
- Height, weight, waist and hip measurements.
- Lean muscle mass will be measured by dual x-ray absorptiometry (DEXA scan).
- Muscle strength will be measured by handgrip, knee extension, and ankle dorsiflexion.
- Walking speed to determine usual walking speed.
- Six-minute walk test to determine endurance.
- Physical activity will be monitored by having the participant complete a survey and wear a small recording device (accelerometer) for seven days.
Study Objectives:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be enrolled on the SJLIFE protocol at St. Jude Children's Research Hospital.
- •18.0-44.99 years of age
- •>10 years post first cancer diagnosis.
- •English speaking.
- •Live within a 45-minute drive of a greater Memphis area ATC Fitness Center
- •Low lean mass defined as either:
- •Age- and sex-specific relative lean muscle mass standard deviation score ≤ -1.
- •Body fat content greater than or equal to 25% in males or greater than or equal to 35% in females.
排除标准
- •Currently pregnant (assessed by serum pregnancy test).
- •Contraindications to resistance training or protein supplementation (e.g. renal) verified by a physician.
结局指标
主要结局
Change in ankle dorsiflexion by arm
时间窗: Baseline and at 24 weeks
Ankle dorsiflexion strength will be evaluated with the Biodex System IV dynamometer.
Change in endurance by arm
时间窗: Baseline and at 24 weeks
Endurance will be evaluated by having participants complete the six minute walk test in a level of corridor as outlined by the American Thoracic Society.
Change in activity level by arm
时间窗: Baseline and at 24 weeks
Participants will complete the physical activity monitor (PAM) component of the most recent release of the National Health and Nutrition Examination Survey to measure activity levels. The PAM collects information on intensity and duration of common activities like walking and jogging for seven consecutive days. Participants will receive an accelerometer with written instructions, programmed to begin recording 12:01 a.m. on the day after the baseline assessment (the week before they begin training) and the day after their final training appointment.
Change in abdominal obesity by arm
时间窗: Baseline and at 24 weeks
Abdominal obesity will be evaluated by measuring waist circumference with a Gulick tape measure to the nearest mm.
Change in lean muscle mass by arm
时间窗: Baseline and at 24 weeks
Dual x-ray absorptiometry (DEXA) will be used to determine lean muscle mass. Fat free mass will be measured in the total body scanning mode.
Change in handgrip by arm
时间窗: Baseline and at 24 weeks
Handgrip strength will be evaluated with a hand held dynamometer.
Change in walking speed by arm
时间窗: Baseline and at 24 weeks
Usual walking speed will be evaluated by having participants complete a timed 10 meter walk test.
Change in high density lipoprotein by arm
时间窗: Baseline and at 24 weeks
High density lipoprotein will be evaluated from fasting blood samples as part of a standard lipid panel.
Change in triglycerides by arm
时间窗: Baseline and at 24 weeks
Triglycerides will be evaluated from fasting blood samples as part of a standard lipid panel.
Change in knee extension by arm
时间窗: Baseline and at 24 weeks
Knee extension strength will be evaluated with the Biodex System IV dynamometer.
Change in blood pressure by arm
时间窗: Baseline and at 24 weeks
Blood pressure will be evaluated with a sphygmomanometer.
Change in fasting glucose by arm
时间窗: Baseline and at 24 weeks
Glucose level will be measured from fasting blood samples.
Change in fasting insulin by arm
时间窗: Baseline and at 24 weeks
Insulin level will be measure from fasting blood samples.
Change in C-reactive protein by arm
时间窗: Baseline and at 24 weeks
Highly sensitive C-reactive protein will be measured from fasting blood samples.
Change in self-reported exhaustion by arm
时间窗: Baseline and at 24 weeks
Measured using the vitality subscale of the Medical Outcomes Survey Short Form-36 (SF-36), version 2.
次要结局
未报告次要终点