Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

FIT FIRST for the Bones (FIT FIRSTftB)

15 de junio de 2026 actualizado por: University of Southern Denmark

FIT FIRST for the Bones - Frequent Intense Training for Lifelong Bone Health

This study aims to conduct a cluster RCT intervention study with adolescents in Denmark and investigate whether the FIT FIRST concept can improve young people's bone health. We hypothesize that students from the schools randomized to the intervention arm will show greater improvements in bone health than students randomized to the control arm. The experiment will be of societal relevance in relation to evidence for the effects of implementing high-intensity physical activity in school.

Descripción general del estudio

Estado

Inscripción por invitación

Condiciones

Intervención / Tratamiento

Descripción detallada

In 2018, the FIT FIRST 10 concept was developed for 6-9 year olds. It included 10 sports, all of which were modified to include both strength and cardio training, but based on sports that you can go to in your spare time, as opposed to many other classic school activities such as roundball, stickball and catch. In 2020, the FIT FIRST 20 concept for 10-12 year olds was developed to include 20 sports, and the FIT FIRST Teen material with more than 20 sports has been released in 2024.

In short, all versions of the FIT FIRST concept are built on the principles of using multiple sports activities modified for the school environment, with a focus on high intensity, high commitment and inclusion. The use of several sports activities that are modified for the school environment can also affect recess and leisure sports, as students are introduced to many fun activities that are easy to organize themselves and/or go to clubs in their spare time.

The implementation of the FIT FIRST concept involves training teachers to deliver the program, which has been developed by experienced staff from the University of Southern Denmark (SDU), the Sports Confederation of Denmark (DIF) and Team Denmark. These partners have developed 3-6 lessons for each of the sports, all using exercises and activities carried out in pairs or small groups. All the lessons included in the FIT FIRST Teen manual are designed to provide high-intensity strength and cardio training and to be motivating for children to participate, according to self-determination theory.

a) Design: A cluster-randomized trial design is used, where school classes are randomly divided into an intervention group that implements the FIT FIRST training concept, and a control group that continues regular schooling.

c) Practical implementation: Schools on Funen will be invited via e-mails, newsletters from the Danish Sports Confederation and social media, and can sign up with 1-2 classes. All students at the participating schools can participate in the survey. The first 10 schools that agree to participate in the study will be randomized into two arms, intervention and control. The intervention arm will implement 3 weekly 40-minute FIT FIRST Teen lessons over the course of 18 weeks, equivalent to half a school year. The teachers who will be responsible for the teaching are trained on a 6-hour theoretical/practical course and the schools receive an equipment package with balls, cones and vests for use in the teaching. The FIT FIRST intervention contains activities that are common in physical education and movement education and will therefore involve the whole class, including the students who are not test subjects in this study. The workout is designed to have elements of high-heart rate training and elements that stimulate bones and muscles. All exercises are based on sports activities you can do in your spare time.

On the test days, all students will also join the class on a trip to the University of Southern Denmark, where only test subjects with consent will participate in trial activities, while others will only participate in sports activities organized by their teacher on the university's campuses, where there are facilities such as a swimming pool and jumping center that make it attractive for the classes to visit.

The schools in the control arm will continue their normal sports curriculum and they will receive the intervention at the end of the trial as a thank you for their efforts. Here, too, the whole class comes on a trip and is allowed to borrow the university's sports facilities.

Bone density will be measured with a whole-body DXA scan before and after the 18 weeks, and bone markers in the blood will be measured via a venous blood sample. In addition, hand grip strength is measured The project will run in 2026.

Tests and measurements:

Anthropometric measurements: Measurement of height and weight is carried out with a portable stadiometer and scale, respectively.

DXA scan: A full-body DXA scan is performed to determine bone mineralization and body composition (fat percentage and muscle mass). The DXA scanner is iDXA Lunar, GE Healthcare. The DXA scan will take place at a hospital or university located close to the school. The test is performed by a radiographer or trained research staff after 0 and 12 weeks.

Blood samples: Blood sampling is performed with a cannula from a vein in the arm for analysis of the concentrations of Osteocalcin, procollagen type I N-terminal propeptide (PINP) and β-C-terminal telopeptide of type I collagen (CTX-I). The blood is collected in 4 ml EDTA glass. Thus, a total of 8 ml of venous blood is collected from each test subject over the two visits.

Muscle strength: Handgrip strength is measured with a handgrip dynamometer (CAMRY).

Intervention The classes in the intervention group will carry out 3 weekly sessions of 40 minutes duration, where they use the FIT FIRST concept with high-intensity, fun and involving training based on sports that you can go to in your spare time. It will be their own teachers who are responsible for the teaching after they have been on a 6 hour course to learn how to use the concept.

4. Statistical considerations.

a) The size of the sample (200 students from a total of 10 classes, 5 in each group) is selected based on an expected effect size of 0.025 g/cm2 on whole-body bone density and a standard deviation of 0.035 g/cm2. Intra Cluster Correlation is expected to be 0.02 g/cm214-16 and the size of the classes is expected to be 20 students on average.

5. Subjects A. Inclusion criteria

  • Healthy boys and girls in 7th+8th grade aged 12-14.99 years.
  • Informed consent of the parents/authority holder(s).
  • Willingness to carry out training and testing.

B. Exclusion Criteria:

• Subjects who are not considered by the researchers to be suitable to follow the protocol/testing and training program.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Funen
      • Odense, Funen, Dinamarca, 5230
        • University of Southern Denmark

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

  • Part of participating classes

Exclusion Criteria:

  • None

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention
3x40 min High Intense training pr week for 18 weeks
Frequent Intense Training (3x40 min pr. week for 18 weeks
Sin intervención: Control
Normal behavior

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
whole-body bone mineral density
Periodo de tiempo: From enrollment to the end of treatment at 18 weeks
A full-body DXA scan is performed to determine bone mineralization
From enrollment to the end of treatment at 18 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
procollagen type I N-terminal propeptide (PINP)
Periodo de tiempo: From enrollment to the end of treatment at 18 weeks
Blood sampling is performed with a cannula from a vein in the arm for analysis of the concentrations
From enrollment to the end of treatment at 18 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Osteocalcin
Periodo de tiempo: From enrollment to the end of treatment at 18 weeks
Blood sampling is performed with a cannula from a vein in the arm for analysis of the concentrations
From enrollment to the end of treatment at 18 weeks
β-C-terminal telopeptide of type I collagen (CTX-I)
Periodo de tiempo: From enrollment to the end of treatment at 18 weeks
Blood sampling is performed with a cannula from a vein in the arm for analysis of the concentrations
From enrollment to the end of treatment at 18 weeks
Leg BMD
Periodo de tiempo: From enrollment to the end of treatment at 18 weeks
full-body DXA scan is performed to determine bone mineralization
From enrollment to the end of treatment at 18 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de enero de 2026

Finalización primaria (Estimado)

20 de diciembre de 2026

Finalización del estudio (Estimado)

20 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • S-20250081

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Not possible within the Danish GDPR regulations

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre FIT FIRST

Suscribir