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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured Progressive Resistance Training Program | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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: Pre-intervention (baseline) and post-intervention (8 weeks) |
| Muscle Strength (Knee Extensor Strength) | Maximum voluntary contraction (MVC) of knee extensors measured using an isokinetic dynamometer. | Time Frame: Pre-intervention and post-intervention (8 weeks) |
| 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). | Throughout the 8-week intervention |
| 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. | Throughout the 8-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Performance | Functional lower-body performance assessed using the 30-second sit-to-stand test (30STS). | Pre-intervention and post-intervention (8 weeks) |
| Body Composition | Body composition assessed using dual-energy X-ray absorptiometry (DXA), including lean mass and fat mass parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Steffl, PhD | Contact | +420778701882 | michal.steffl@ftvs.cuni.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Education and Sport Charles University | Prague | Czech Republic | 16200 | Czechia |
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| Pre-intervention and post-intervention (8 weeks) |