- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512570
Feasibility and Preliminary Effects of a Structured Resistance Training Program in Children Aged 10-14 Years
Feasibility and Preliminary Effects of a Structured Resistance Training Programme in Children Aged 10-14 Years: A Randomised Controlled Pilot Study
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michal Steffl, PhD
- Phone Number: +420778701882
- Email: michal.steffl@ftvs.cuni.cz
Study Locations
-
-
Czech Republic
-
Prague, Czech Republic, Czechia, 16200
- Faculty of Physical Education and Sport Charles University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Time Frame: Pre-intervention (baseline) and post-intervention (8 weeks)
|
|
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.
|
Time Frame: Pre-intervention and post-intervention (8 weeks)
|
|
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).
|
Throughout the 8-week intervention
|
|
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.
|
Throughout the 8-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Performance
Time Frame: Pre-intervention and post-intervention (8 weeks)
|
Functional lower-body performance assessed using the 30-second sit-to-stand test (30STS).
|
Pre-intervention and post-intervention (8 weeks)
|
|
Body Composition
Time Frame: Pre-intervention and post-intervention (8 weeks)
|
Body composition assessed using dual-energy X-ray absorptiometry (DXA), including lean mass and fat mass parameters.
|
Pre-intervention and post-intervention (8 weeks)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EK 007/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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