NCT06594900: decade-fit

Development of Muscle Function in Prepubertal Children As a Response to Growth and Resistance Training

ENROLLING BY INVITATION NA Last updated 5 March 2025

What this trial tests

NA trial testing resistance training intervention in Focus on Healthy Infants in 52 participants. Enrolling by invitation.

Timeline

19 November 2024

Primary endpoint
15 September 2027

30 December 2027

Quick facts

Lead sponsor	Ralf Roth
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	19 November 2024
Primary completion	15 September 2027
Estimated completion	30 December 2027
Sites	1 location across Switzerland

Drugs / interventions tested

• resistance training intervention

Conditions studied

• Focus on Healthy Infants — all drugs for Focus on Healthy Infants →

Sponsor

Ralf Roth — full company profile →

Who can join

Adults 7 to 11, any sex, with Focus on Healthy Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.