Feasibility and Preliminary Effects of a Structured Resistance Training Program in Children Aged 10-14 Years

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorCharles University, Czech Republic

About this trial

This study is a randomised controlled pilot trial designed to evaluate the feasibility, safety, and preliminary efficacy of a 12-week resistance training intervention in children aged 10-14 years. The study adheres to the CONSORT extension for randomised pilot and feasibility trials and incorporates key elements of the SPIRIT guidelines for clinical trial protocols.

The primary purpose of the study is to assess feasibility-related outcomes and to generate effect size estimates to inform the design of a subsequent fully powered randomised controlled trial (RCT).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 10-14 years

Ability to safely participate in supervised resistance training

Written informed consent from a parent or legal guardian

Assent provided by the child participant

Disqualifiers

Acute illness at the time of enrolment

Recent musculoskeletal injury or immobilisation

Chronic cardiovascular, metabolic, or endocrine disorders

Use of medications that may affect muscle composition or function

Trial design

Design model

Single group

Treatments tested in this trial

  • Progressive Resistance Training Program

    Behavioral

    An 8-week supervised progressive resistance training (PRT) program performed twice weekly in children aged 10-14 years. Each \~45-minute session includes a warm-up, whole-body resistance exercises (with emphasis on lower-limb musculature), and a cool-down. Exercises include squat variations, hip hinge movements, unilateral lower-limb exercises, upper-body pushing and pulling, and core stabilization. Training intensity is prescribed using a youth-specific rating of perceived exertion (RPE 5-8), with progressive overload applied individually based on proper technique. The program is divided into three phases: familiarisation (weeks 1-2), progressive overload (weeks 3-5), and strength-oriented training (weeks 6-8). Sessions are delivered in small groups under qualified supervision to ensure safety and adherence.

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: Structured Progressive Resistance Training ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Muscle Quality (Echo Intensity)

Ultrasound-derived echo intensity (EI) of the quadriceps femoris (QF) muscle assessed as an indicator of skeletal muscle quality. EI will be derived from longitudinal scans of each QF head and the cross-sectional area (CSAQF) from panoramic mid-thigh images

Time frame
Time Frame: Pre-intervention (baseline) and post-intervention (8 weeks)
2

Muscle Strength (Knee Extensor Strength)

Maximum voluntary contraction (MVC) of knee extensors measured using an isokinetic dynamometer.

Time frame
Time Frame: Pre-intervention and post-intervention (8 weeks)
3

Feasibility of the Intervention

Feasibility assessed by recruitment rate, retention rate, and adherence to the training program (percentage of sessions attended and proportion of participants attending ≥80% of sessions).

Time frame
Throughout the 8-week intervention
4

Safety of the Intervention

Safety evaluated by the number, type, and severity of adverse events recorded during training sessions, and the proportion of participants experiencing at least one adverse event.

Time frame
Throughout the 8-week intervention

Secondary outcomes

1

Functional Performance

Functional lower-body performance assessed using the 30-second sit-to-stand test (30STS).

Time frame
Pre-intervention and post-intervention (8 weeks)
2

Body Composition

Body composition assessed using dual-energy X-ray absorptiometry (DXA), including lean mass and fat mass parameters.

Time frame
Pre-intervention and post-intervention (8 weeks)

Other outcomes

Sponsors and contacts

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