Design and Validation of a Personalized Preventive System for Adolescents Based on Biological Maturity, Body Composition, and Musculoskeletal Function.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Lower-limb Strength (Isometric)
研究概览
简要总结
This study aims to evaluate the effectiveness of a personalized preventive physiotherapy and exercise program based on biological maturation status in adolescents aged 14 to 15 years. During adolescence, rapid growth and differences in biological maturation can increase the risk of musculoskeletal imbalances, pain, and injuries, especially in physically active youth. However, most preventive programs are designed according to chronological age rather than biological development.
Participants will be assessed using non-invasive methods to determine biological maturation, body composition, and musculoskeletal function, including strength, balance, mobility, and postural control. Based on these assessments, participants in the intervention group will receive a 12-week individualized preventive physiotherapy program adapted to their maturation stage, while the control group will continue with their usual school or sports activities without structured intervention.
The study will compare changes in musculoskeletal function, body composition, pain perception, and lifestyle-related variables between baseline and post-intervention assessments. The results are expected to provide evidence for a maturation-based preventive approach that can be applied in clinical, school, and sports settings to reduce injury risk and improve musculoskeletal health in adolescents.
详细描述
Adolescence is a critical period of physical development characterized by rapid growth and significant interindividual variability in biological maturation. These changes can temporarily affect coordination, strength, and musculoskeletal balance, increasing the risk of pain, functional limitations, and sports-related injuries. Traditional preventive and training programs are commonly based on chronological age, which may not adequately reflect an adolescent's true biological development.
This study is a prospective, longitudinal, interventional study with a pre-post design and a non-randomized control group. A total of approximately 120 adolescents aged 14 to 15 years will be recruited from educational and sports institutions. Participants will be allocated to either an intervention group or a control group.
At baseline, all participants will undergo a comprehensive non-invasive assessment including anthropometry, estimation of biological maturation using validated predictive equations for peak height velocity, body composition analysis, and musculoskeletal function tests assessing strength, balance, mobility, and core stability. Subjective measures such as pain perception, sleep quality, physical activity level, and general well-being will also be collected using validated questionnaires.
Participants in the intervention group will complete a 12-week personalized preventive physiotherapy and exercise program, consisting of two supervised sessions per week. The program will be tailored to each participant's maturation status and functional profile, focusing on neuromuscular control, mobility, strength development, and postural stability. Periodic reassessments will allow for individualized progression and adjustment of the intervention. The control group will continue with their usual routines without receiving a structured preventive program.
Post-intervention assessments will replicate baseline measurements to evaluate changes over time. The primary outcomes will include changes in musculoskeletal function parameters, while secondary outcomes will assess body composition, pain perception, lifestyle variables, and adherence to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents aged 14 to 15 years at the time of enrollment.
- •Male and female participants.
- •Apparently healthy adolescents without diagnosed chronic medical conditions.
- •Participation in regular school physical education and/or organized sports activities.
- •Ability to participate in moderate physical activity as determined by a pre-participation screening.
- •Written informed consent obtained from parents or legal guardians, and assent from the participant.
排除标准
- •Presence of acute or chronic musculoskeletal injury that limits participation in physical activity at the time of enrollment.
- •History of musculoskeletal surgery within the previous 12 months.
- •Diagnosed neurological, cardiovascular, metabolic, or systemic disease that contraindicates physical exercise.
- •Current participation in another structured exercise or intervention study.
- •Use of medication that may significantly affect musculoskeletal function or physical performance.
- •Any condition that, in the opinion of the investigators, could compromise participant safety or adherence to the protocol.
研究组 & 干预措施
Usual Activity Control Group
Participants in this arm will continue with their usual school and/or sports activities without receiving a structured preventive physiotherapy or exercise program. They will undergo the same baseline and post-intervention assessments as the intervention group for comparison purposes.
Personalized Preventive Physiotherapy Program
Participants in this arm will receive a personalized preventive physiotherapy and exercise program tailored to their biological maturation status and functional profile. The intervention will last 12 weeks and will include two supervised sessions per week focusing on neuromuscular control, strength development, mobility, balance, and postural stability. Periodic reassessments will allow individualized progression and adjustment of the program throughout the intervention period.
干预措施: Personalized Preventive Physiotherapy and Exercise Program (Behavioral)
结局指标
主要结局
Lower-limb Strength (Isometric)
时间窗: Baseline and 12 weeks
Change in lower-limb isometric strength assessed using digital dynamometry during standardized testing procedures.
Postural Balance
时间窗: Baseline and 12 weeks
Change in postural balance assessed using instrumented balance testing (e.g., force platform and inertial sensors) during standardized static and dynamic tasks.
次要结局
- Mobility / Range of Motion(Baseline and 12 weeks)
- Postural Control(Baseline and 12 weeks)
- Core Stability / Core Control(Baseline and 12 weeks)
- Vertical Jump Performance(Baseline and 12 weeks)
- Fat Mass(Baseline and 12 weeks)
- Skeletal Muscle Mass(Baseline and 12 weeks)
- Phase Angle(Baseline and 12 weeks)
- Maturity Offset(Baseline and 12 weeks)
- Peak Height Velocity (PHV) Status(Baseline and 12 weeks)
- Musculoskeletal Pain Intensity(Baseline and 12 weeks)
- Physical Activity Level (PAQ-A)(Baseline and 12 weeks)
- Sleep Quality(Baseline and 12 weeks)
- Intervention Adherence(Baseline and 12 weeks)
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Professor of Health Sciences
University of Alicante