Clinical trial NCT06594900: Development of Muscle Function in Prepubertal Children As a Response to Growth and Resistance Training
Official title: Muscle Growth and Development of Neuromuscular Capacities in Prepubertal Children - a Randomized Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Focus on Healthy Infants
Keywords: resistance training
strength training
children
prepubertal children
health
neuromuscular capacities
neurmuscular
development
crossfit
functional training
weigth training
neuromuscular adaptation
hormonal adaptation
structural adaptation
morphological adaptation
children development
physiological adaptation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: maximal isometric voluntary contraction of knee extensor muscles
timeFrame: 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.
Secondary outcomes:
measure: Neuromuscular fatiguability
timeFrame: 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.
measure: Power and explosive force
timeFrame: 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.
measure: Voluntary activation
timeFrame: 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.
measure: Muscle size
timeFrame: 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.
measure: Motor unit activity
timeFrame: 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.
measure: Acute and chronic hormonal changes
timeFrame: 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
measure: Muscle fascicle shortening velocity
timeFrame: 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.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Sport, Exercise and Health
state: Basellandschaft
Study officials:
References: