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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Progressive Resistance Training Program
BehavioralAn 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
Trial outcomes
Primary outcomes
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
Muscle Strength (Knee Extensor Strength)
Maximum voluntary contraction (MVC) of knee extensors measured using an isokinetic dynamometer.
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).
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.
Secondary outcomes
Functional Performance
Functional lower-body performance assessed using the 30-second sit-to-stand test (30STS).
Body Composition
Body composition assessed using dual-energy X-ray absorptiometry (DXA), including lean mass and fat mass parameters.
Sponsors and contacts
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