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临床试验/NCT03720015
NCT03720015已完成不适用

Concurrent Training and Nutritional Management Prevent Body Weight Loss During Radiotherapy in a Young Adult With Head and Neck Cancer: A Case Control Study

Universidad Francisco de Vitoria1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Body weight in kilograms (kg)

研究概览

简要总结

A case control study with before-after design. A concurrent training and a nutritional management intervention was offered by a patient with head and neck cancer, in order to compare outcomes related to strength and endurance performance and to body composition

详细描述

Cancer causes important public health problems around the world and it is one of the most frequent cause of death overall. Among non-pharmacological treatment, physical exercise has shown improvements in different types of cancer and patients, but it is important to define the optimal dose. Our aim is to determine the effects of a concurrent training program and a nutritional management developed during radiotherapy treatment on physical performance and body composition. A patient with an oral cavity cancer will develop three sessions per week of concurrent training: resistance training included 9 standard exercises involving major muscle groups (4x8-12 RM), and cardiovascular training included a High-Intensity Interval Training (HIIT). Nutritional management will include a diet controlling macronutrients (~4g/kg/day for carbohidrates, ~2g/kg/day for proteins, and ~1g/kg/day for fats), along with some nutritional supplements such as beta-hydroxybeta-methylbutyrate (HMB), arginine, glutamine, omega-3 fish oil concentrate, and BCAA's during training sessions. Intervention took place during radiotherapy period (7 weeks). We expect that body composition will remain invariable, and 1RM will increased. VO2max is expected to be almost the same, but intensity tolerated at maximum VO2max could be higher. If our results confirm that, we could conclude that a combination between resistance exercise and HIIT along with a nutritional management developed during radiotherapy could be effective to prevent muscle mass loss and muscle function decrease in a young patient with oral cavity cancer.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
32 Years 至 34 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •This is a case control study

排除标准

  • 未提供

研究组 & 干预措施

Concurrent training

Experimental

Three sessions per week of concurrent training during radiotherapy period. Each session will begin with warm-up (5-min cardiovascular activity at low-moderate intensity, joint mobility and one set of resistance exercises circuit at 30-40% 1RM). Resistance training will follow the warm-up, including 9 standard exercises involving major muscle groups of the lower and upper body: vertical bench press, parallel bar dip for triceps, seated rowing, standing dumbbell curl for biceps, leg press, deadlift and shoulder press. All these exercises will be realized following circuit training with 4 sets of 8-12 repetitions, using a training load of 70-80% RM. When patient will able to complete more than 12 repetitions, load will be increased progressively 10%. Cardiovascular training will be completed 20-30 min after resistance training, and it will include High-Intensity Interval Training (HIIT) of 3 min near to the second ventilatory threshold and 2 min near to the first ventilatory threshold.

干预措施: Physical exercise (Behavioral)

Nutritional management

Experimental

Prescribed diet controlling macronutrients according to patient body weight (~4g/kg/day for carbohidrates, ~2g/kg/day for proteins, and ~1g/kg/day for fats). Patient will take one single dosage per day of probiotics (Arkoprobiotics® Defenses), 1 or 2 capsules of omega-3 fish oil concentrate (Solgar®, 600-1200mg depending on fat sources intake during the day), and a combine ingestion of 3g beta-hydroxybeta-methylbutyrate (HMB), 14g arginine, and 14g glutamine (HSN Raw Series®, all pure ingredients and making the ingestion adding each of them individually in a solution with 300-400 ml of water). During concurrent training sessions, between resistance exercise and HIIT, patient will also take 6g of BCAA's (HSN Raw Series®, 2:1:1) along with a banana. Additionally, patient could take whey isolated protein (Amix® IsoPrime CFM) to meet with some of the prescribed proteins intakes.

干预措施: Nutritional management (Dietary Supplement)

结局指标

主要结局

Body weight in kilograms (kg)

时间窗: 8 weeks

Total fat in percentage (%)

时间窗: 8 weeks

Lean body mass in percentage (%)

时间窗: 8 weeks

Visceral adipose tissue in cm2

时间窗: 8 weeks

次要结局

  • Maximal oxygen uptake (VO2max) in ml/kg/min(8 weeks)
  • 1 repetition maximal (1RM) for upper-body in kilograms (kg)(8 weeks)
  • 1 repetition maximal (1RM) for lower-body in kilograms (kg)(8 weeks)
  • Power at VO2max in watts (W)(8 weeks)

研究者

发起方
Universidad Francisco de Vitoria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Berlanga

Principal Investigator

Universidad Francisco de Vitoria

研究点 (1)

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