跳至主要内容
临床试验/NCT06594900
NCT06594900Enrolling By Invitation不适用

Muscle Growth and Development of Neuromuscular Capacities in Prepubertal Children - a Randomized Controlled Intervention Study

Ralf Roth2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
52
试验地点
2
主要终点
maximal isometric voluntary contraction of knee extensor muscles

研究概览

简要总结

Healthy skeletal muscle development is crucial for a life-long quality of life. Childhood and puberty may be key periods for developing muscle growth and neuromuscular capacities, which are essential for bone-muscle interaction, metabolism, and participation in various sports. Even though the central role of physical activity in healthy physical development is well recognized, the decline in muscular fitness in today's children is alarming. This can lead to lasting deficits in muscle development and have a negative impact on overall health.

Well-designed resistance training (RT) could address this problem, since it has an effective positive impact on muscular strength, bone density, metabolism, and spontaneous physical activity especially in childhood. In general, muscles adapt according to physical activity stimuli. However, children show different responses to exercise and training. The physiologic differences, which are reflected in lower neuromuscular capacities and hormonal responses, but also in a better resistance to fatigue than in adults, are not yet fully understood. It is well established, that RT in children is safe, effective and has multiple benefits for health. However, the underlying mechanisms that lead to increased muscle strength are unclear and it is unknown how sustainable these are.

Today's common conception is that increased muscular strength is predominantly caused by neural adaptations and changes in muscle morphology due to lower androgenic responses are negligible.

Although higher neuromuscular adaptation potential is evident, it is still not sufficient to explain all strength increases, suggesting that additional mechanisms are involved in the process. Most studies are outdated, had methodological and statistical limitations, and many state-of-the-art methods have not yet been applied to children, hence, there is a need for a comprehensive, in-depth investigation to understand muscle adaptations to training and growth in children. With this better understanding of the impact and adaption to RT stimuli on neuromuscular and structural development the proposed project can serve as a foundation for more targeted prevention strategies.

The aim of this study is to investigate neuromuscular, hormonal, and morphological adaptations following 4 and 20 weeks of RT, while also examining their longitudinal retention through two consecutive follow-ups over 1.5 years. In this randomized controlled trial, state-of-the-art measurement methods are employed to accurately delve into mechanisms of adaptation, some of which have not yet used in children before due to limited time or infrastructure resources. The neuromuscular assessments include maximal and explosive strength of leg extensors, voluntary activation, motor unit decomposition, as well as central and peripheral neuromuscular fatigability. The hormonal changes are measured acutely (testosterone, cortisol, IGF-1 and growth hormone) and chronically (testosterone, progesterone and IGF-1) in response to one or several training sessions. Static and dynamic ultrasound imagining is used to quantify muscle size, fascicle shortening velocity and muscle architecture. This design allows in-depth insights into short- and long-term adaptations on several physiological levels to provide a novel mechanistic understanding of muscle growth and function in children.

The major innovation of this research is the integration of diverse scientific perspectives, combining insights from neuromuscular physiology, endocrinology, and muscle morphology to provide a holistic understanding of RT adaptations and development in children of both sexes.

This comprehensive approach can form the basis for future training programs, enabling next generations to better understand the potential impact of musculature on health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Able to travel 6 times to the Departement of Sports, Exercise and Health for the measurements
  • Able to travel 2 times per week to CrossFit Basel GmbH for 20 weeks to participate on the training
  • Able to verbally communicate pain or discomfort
  • Signed informed consent information from the parents

排除标准

  • Any acute or chronic medical condition
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  • Regular participation in resistance training (incl. CrossFit®) in the previous year.

结局指标

主要结局

maximal isometric voluntary contraction of knee extensor muscles

时间窗: From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.

Maximal isometric voluntary contraction (MVC) of knee extensor muscles refers to the level of maximal force, which can be transferred to a resisted dynamometer. It is highly adaptive from stimuli like training through mainly two pathway: by neuromuscular adaptation or muscle hypertrophy. Therefore, this is a sensitive measure during growth and resistance training intervention. The measurement of isometric MVC of knee extensor muscles will be performed in a seated position in a dynamometer (Isomed 2000, D. \& R. Ferstl GmbH, Germany). The test subjects are fixed at a hip and knee angle of 120° and 60° respectively. According to Maffiuletti et al. (2016) the subjects are instructed to extend their legs as fast and forceful as possible and hold the contraction for 3-5s against lever arm of the dynamometer. After a familiarization attempt, the measurement is performed 2-5 times (until \<5% difference between two trials) with a rest of 1 min in between. Peak torque will be used as outcome.

次要结局

  • Neuromuscular fatiguability(From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.)
  • Power and explosive force(From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.)
  • Voluntary activation(From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.)
  • Muscle size(From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.)
  • Motor unit activity(From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.)
  • Acute and chronic hormonal changes(Resting concentrations: from enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each. Acute changes from one training session: in 2nd and 2nd-last week)
  • Muscle fascicle shortening velocity(From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.)

研究者

发起方
Ralf Roth
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ralf Roth

Principal Investigator

University Hospital, Basel, Switzerland

研究点 (2)

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