Feasibility and Preliminary Effects of a Structured Resistance Training Programme in Children Aged 10-14 Years: A Randomised Controlled Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Muscle Quality (Echo Intensity)
Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Willingness to comply with all study procedures and attend training sessions
Exclusion Criteria
- •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
- •Any medical or psychological condition that may compromise safety or adherence
Arms & Interventions
Structured Progressive Resistance Training Program
Participants will complete an 8-week supervised progressive resistance training (PRT) program performed twice weekly. Each ~45-minute session includes a warm-up, whole-body resistance exercises (with emphasis on lower limbs), and a cool-down. Exercises include squat variations, hip hinge movements, unilateral lower-limb exercises, upper-body pushing/pulling, and core stabilization.
Training intensity is guided by a youth-specific RPE scale (5-8), with progressive overload based on individual technique. Sessions are delivered in small groups under qualified supervision to ensure safety and adherence.
The program consists of three phases: familiarisation (weeks 1-2), progressive overload (weeks 3-5), and strength-oriented training (weeks 6-8). Outcomes are assessed pre- and post-intervention.
Intervention: Progressive Resistance Training Program (Behavioral)
Outcomes
Primary Outcomes
Muscle Quality (Echo Intensity)
Time Frame: Time Frame: Pre-intervention (baseline) and post-intervention (8 weeks)
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)
Time Frame: Time Frame: Pre-intervention and post-intervention (8 weeks)
Maximum voluntary contraction (MVC) of knee extensors measured using an isokinetic dynamometer.
Feasibility of the Intervention
Time Frame: Throughout the 8-week 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
Time Frame: Throughout the 8-week 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(Pre-intervention and post-intervention (8 weeks))
- Body Composition(Pre-intervention and post-intervention (8 weeks))
Investigators
Michal Šteffl
Head of Department
Charles University, Czech Republic