Musculoskeletal HealthPREVEN-KIDNCT07385794
Design and Validation of a Personalized Preventive System for Adolescents Based on Biological Maturity, Body Composition, and Musculoskeletal Function.
A study testing Personalized Preventive Physiotherapy and Exercise Program in people with Musculoskeletal Health and Adolescent Growth and Development, run by University of Alicante at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Health, Adolescent Growth and Development, Injury Prevention
- What is being tested?
- Personalized Preventive Physiotherapy and Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
The findings of this study aim to support the use of biologically informed preventive strategies in adolescents and to contribute to the development of scalable, evidence-based programs for clinical, educational, and sports environments.
- Being tested
- Personalized Preventive Physiotherapy and Exercise Program
- Keywords
- Adolescents, Biological maturation, Peak height velocity, Musculoskeletal function, Injury prevention, Physiotherapy, Preventive exercise, Physical development, Youth athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Preventive Physiotherapy and Exercise ProgramBehavioural
This intervention consists of a personalized preventive physiotherapy and exercise program designed according to each participant's biological maturation status and functional assessment. The program lasts 12 weeks and includes two supervised sessions per week. Sessions focus on neuromuscular control, strength development, mobility, balance, core stability, and postural control. The intervention is individualized based on baseline and periodic reassessments, allowing progression and adjustment throughout the program. All sessions are supervised by qualified professionals.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Preventive Physiotherapy Program | Experimental | 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. Receives: Behavioral: Personalized Preventive Physiotherapy and Exercise Program |
| Usual Activity Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-limb Strength (Isometric)
Change in lower-limb isometric strength assessed using digital dynamometry during standardized testing procedures.
Measured: Baseline and 12 weeks
Postural Balance
Change in postural balance assessed using instrumented balance testing (e.g., force platform and inertial sensors) during standardized static and dynamic tasks.
Measured: Baseline and 12 weeks
Secondary outcomes (13)
Mobility / Range of Motion
Change in joint mobility assessed as active range of motion using motion sensors or standardized mobility tests.
Measured: Baseline and 12 weeks
Postural Control
Change in postural control parameters derived from instrumented postural assessment (e.g., center of pressure metrics and/or inertial sensor outputs) during standardized tasks.
Measured: Baseline and 12 weeks
Core Stability / Core Control
Change in core stability assessed using a standardized core control test protocol (e.g., ICAROS-based assessment).
Measured: Baseline and 12 weeks
Vertical Jump Performance
Change in vertical jump performance assessed using squat jump and/or countermovement jump measured with a load cell or force platform.
Measured: Baseline and 12 weeks
Fat Mass
Change in fat mass assessed using multi-frequency bioelectrical impedance analysis and/or anthropometric assessment, following standardized procedures.
Measured: Baseline and 12 weeks
Skeletal Muscle Mass
Change in skeletal muscle mass and/or fat-free mass assessed using multi-frequency bioelectrical impedance analysis, following standardized procedures.
Measured: Baseline and 12 weeks
Phase Angle
Change in phase angle derived from multi-frequency bioelectrical impedance analysis.
Measured: Baseline and 12 weeks
Maturity Offset
Change in maturity offset estimated using validated anthropometric equations.
Measured: Baseline and 12 weeks
Peak Height Velocity (PHV) Status
Change in estimated PHV status (pre-, circa-, post-PHV) derived from validated predictive equations.
Measured: Baseline and 12 weeks
Musculoskeletal Pain Intensity
Change in self-reported musculoskeletal pain intensity assessed using a standardized pain rating scale.
Measured: Baseline and 12 weeks
Physical Activity Level (PAQ-A)
Change in physical activity level assessed using the Physical Activity Questionnaire for Adolescents (PAQ-A).
Measured: Baseline and 12 weeks
Sleep Quality
Change in self-reported sleep quality assessed using a standardized questionnaire.
Measured: Baseline and 12 weeks
Intervention Adherence
Adherence measured as the percentage of completed supervised sessions out of the total prescribed sessions during the 12-week intervention.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either a personalized preventive physiotherapy and exercise intervention group or a usual activity control group, and followed in parallel with pre- and post-intervention assessments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385794
- Sponsor's protocol ID
- UA-2025-12-13
- Other IDs
- INNTA3/2025/8
- Acronym
- PREVEN-KID
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Validation of a Personalized Preventive System for Adolescents Based on Biological Maturity, Body Composition, and Musculoskeletal Function.
- ClinicalTrials.gov ID
- NCT07385794
- Acronym / sponsor ID
- PREVEN-KID / UA-2025-12-13
- Keywords
- Adolescents, Biological maturation, Peak height velocity, Musculoskeletal function, Injury prevention, Physiotherapy, Preventive exercise, Physical development
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The findings of this study aim to support the use of biologically informed preventive strategies in adolescents and to contribute to the development of scalable, evidence-based programs for clinical, educational, and sports environments.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to either a personalized preventive physiotherapy and exercise intervention group or a usual activity control group, and followed in parallel with pre- and post-intervention assessments.
| Arm | Type | Receives |
|---|---|---|
| Personalized Preventive Physiotherapy Program | Experimental | Behavioral: Personalized Preventive Physiotherapy and Exercise ProgramParticipants 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. |
| Usual Activity Control Group | No intervention | –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. |
Who may qualify
- Ages
- 14 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Preventive Physiotherapy and Exercise ProgramThis intervention consists of a personalized preventive physiotherapy and exercise program designed according to each participant's biological maturation status and functional assessment. The program lasts 12 weeks and includes two supervised sessions per week. Sessions focus on neuromuscular control, strength development, mobility, balance, core stability, and postural control. The intervention is individualized based on baseline and periodic reassessments, allowing progression and adjustment throughout the program. All sessions are supervised by qualified professionals. | Behavioural | Personalized Preventive Physiotherapy Program |
Primary outcome
Lower-limb Strength (Isometric)
Time frame: Baseline and 12 weeks
Change in lower-limb isometric strength assessed using digital dynamometry during standardized testing procedures.
Postural Balance
Time frame: 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.
13 secondary outcomes
Mobility / Range of Motion
Time frame: Baseline and 12 weeks
Postural Control
Time frame: Baseline and 12 weeks
Core Stability / Core Control
Time frame: Baseline and 12 weeks
Vertical Jump Performance
Time frame: Baseline and 12 weeks
Fat Mass
Time frame: Baseline and 12 weeks
Skeletal Muscle Mass
Time frame: Baseline and 12 weeks
Phase Angle
Time frame: Baseline and 12 weeks
Maturity Offset
Time frame: Baseline and 12 weeks
Peak Height Velocity (PHV) Status
Time frame: Baseline and 12 weeks
Musculoskeletal Pain Intensity
Time frame: Baseline and 12 weeks
Physical Activity Level (PAQ-A)
Time frame: Baseline and 12 weeks
Sleep Quality
Time frame: Baseline and 12 weeks
Intervention Adherence
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Preventive Physiotherapy and Exercise Program in people with Musculoskeletal Health and Adolescent Growth and Development, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower-limb Strength (Isometric) (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.