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Effect of Knee Position on Muscle Loss During Leg Immobilization

1 de julio de 2026 actualizado por: Marlou Dirks, Wageningen University

A Novel Angle: Manipulating Knee Position to Understand Muscle Deterioration During Leg Immobilization

This study looks at what happens to leg muscles when the knee is kept straight or bent during five days of wearing a brace. We want to find out if keeping the knee bent (so the thigh muscle is stretched) helps prevent muscle loss compared to keeping the knee straight. Thirty healthy adults will take part. They will wear a knee brace for five days and have several tests before and after, including scans, blood samples, and small muscle samples. The results may help doctors find better ways to protect muscles when people cannot move, for example after surgery or illness.

Descripción general del estudio

Descripción detallada

Short periods of physical inactivity, as occur during illness, surgery, or injury, lead to rapid and substantial losses of muscle mass, strength, and metabolic health, often with incomplete recovery in vulnerable individuals. In older adults, repeated bouts of disuse are thought to contribute significantly to age-related sarcopenia. Despite decades of research, the underlying mechanisms remain incompletely elucidated, and effective therapeutic interventions are lacking.

Mechanistically, any muscle atrophy must occur due to a negative muscle protein net balance (MPNB), which can be caused by a decline in muscle protein synthesis (MPS), an increase in muscle protein breakdown (MPB), or a combination of both. Normally, exercise and dietary protein stimulate MPS and maintain muscle mass. During disuse, however, exercise is often impossible, and inactive muscle shows a blunted response to dietary protein. Consequently, these potent strategies become ineffective or even harmful in inactive individuals, highlighting the need for alternative approaches.

Animal studies indicate that immobilizing a muscle in a lengthened (stretched) position can attenuate disuse-induced muscle atrophy and functional decline compared to a shortened position. Whether this phenomenon also occurs in humans, and whether passive muscle length and tension influence muscle metabolism during disuse, remain unexplored.

The objective of this study is to assess whether immobilizing the quadriceps in a lengthened versus neutral position during disuse attenuates losses of muscle mass, function, and metabolic health.

In this randomized, controlled human intervention study with 2 parallel groups 30 healthy, normal weight males and females (18-40 years old, BMI between 18 and 30 kg·m-2) will undergo 5 days of unilateral leg immobilization using a knee brace that prevents voluntary quadriceps contraction. In the neutral group, the leg is fixed in full extension (0° flexion), while in the lengthened group it is fixed at 60° flexion, stretching the quadriceps.

The effects on muscle protein net balance (MPNB), quadriceps muscle volume , muscle quality, muscle strength, fatigue resistance, and muscle mitochondrial bioenergetics will be assessed.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

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

  • Adulto

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

  • Healthy males and females
  • Aged from 18-40 years at the time of signing informed consent
  • 18.5 < BMI < 30 kg·m-2
  • Must be willing and able to communicate and participate in the whole study

Exclusion Criteria:

  • Smoking
  • Diabetes (Type 1, Type 2, or genetic form of diabetes)
  • Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
  • Chronic use of any prescribed or over the counter pharmaceuticals that may modulate muscle protein metabolism (excluding oral contraceptives and contraceptive devices).
  • A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
  • Prone to keloid forming (i.e. hyperplastic growth of scars).
  • Any known disorders in muscle metabolism
  • Regular use of dietary protein and/or amino acid supplements (>3 times per week)
  • Currently involved in a structured progressive resistance training programme (>3 times per week)
  • Known allergy to lidocaine
  • Known severe kidney problems
  • Allergy to one or multiple amino acids
  • Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture)
  • Having received or ingested a stable isotope tracer containing 15N in the past
  • Contra-indications for MRI such as incompatible metal objects in the body and claustrophobia.
  • Currently taking part in other scientific research
  • Pregnant or breastfeeding
  • Unable to give consent

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Neutral Knee Position
Participants in this group wear a knee brace in full extension (0°) for five consecutive days.
Unilateral knee immobilization at 0° flexion for 5 days using a brace; post-immobilization metabolic testing with tracer infusions and biopsies
Experimental: Flexed Knee Position
Participants in this group wear a knee brace in flexion (60°) for five consecutive days.
Unilateral knee immobilization at 60° flexion for 5 days using a brace; post-immobilization metabolic testing with tracer infusions and biopsies

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Muscle protein net balance (MPNB)
Periodo de tiempo: Baseline to 3 hours after tracer infusion
Muscle protein net balance expressed as %/h and calculated as the difference between muscle protein synthesis (MPS; fractional synthesis rate, FSR) and muscle protein breakdown (MPB; fractional breakdown rate, FBR), measured in skeletal muscle following 5 days of unilateral knee immobilization
Baseline to 3 hours after tracer infusion

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Thigh muscle volume
Periodo de tiempo: Baseline and after 5 days of immobilization
Thigh muscle volume, including muscle length and cross-sectional area, measured via Magnetic Resonance Imaging (MRI)
Baseline and after 5 days of immobilization
Muscle strength
Periodo de tiempo: Baseline and after 5 days of immobilization
Maximal voluntary muscle strength measured as peak torque using isokinetic dynamometry
Baseline and after 5 days of immobilization
Muscle fatigue
Periodo de tiempo: Baseline and after 5 days of immobilization
Muscle fatigue assessed as decline in force during repeated contractions measured using isokinetic dynamometry
Baseline and after 5 days of immobilization
Intramuscular fat content
Periodo de tiempo: Baseline and after 5 days of immobilization
Intramuscular lipid content measured using 1H-magnetic resonance spectroscopy (1H-MRS)
Baseline and after 5 days of immobilization
Muscle metabolite concentrations
Periodo de tiempo: Baseline and after 5 days of immobilization
Carnosine and acetylcarnitine concentrations in skeletal muscle measured using 1H-magnetic resonance spectroscopy (1H-MRS)
Baseline and after 5 days of immobilization
Mitochondrial respiration
Periodo de tiempo: Baseline and after 5 days of immobilization
Mitochondrial respiration measured as oxygen consumption in permeabilized muscle fibres using high-resolution respirometry
Baseline and after 5 days of immobilization
Mitochondrial reactive oxygen species production
Periodo de tiempo: Baseline and after 5 days of immobilization
Mitochondrial reactive oxygen species (ROS) production measured using fluorescence-based detection in permeabilized muscle fibres
Baseline and after 5 days of immobilization
Mitochondrial calcium retention capacity
Periodo de tiempo: Baseline and after 5 days of immobilization
Calcium retention capacity measured in permeabilized muscle fibres using fluorescence-based assays
Baseline and after 5 days of immobilization
Muscle gene expression related to atrophy
Periodo de tiempo: Baseline and after 5 days of immobilization
Expression of genes involved in muscle atrophy measured in skeletal muscle biopsy samples using molecular analysis techniques (e.g. qPCR or RNA sequencing)
Baseline and after 5 days of immobilization
Muscle protein markers of atrophy
Periodo de tiempo: Baseline and after 5 days of immobilization
Protein expression of markers related to muscle protein synthesis and breakdown measured in skeletal muscle biopsy samples
Baseline and after 5 days of immobilization

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Height
Periodo de tiempo: Baseline (pre-intervention)
Height measured in meters
Baseline (pre-intervention)
Plasma amino acid concentration
Periodo de tiempo: Baseline to 3 hours after tracer infusion
Plasma concentration of amino acids measured in venous blood samples
Baseline to 3 hours after tracer infusion
Serum insulin concentration
Periodo de tiempo: Baseline and up to 3 hours after tracer infusion
Serum insulin concentration measured in venous blood samples
Baseline and up to 3 hours after tracer infusion
Body weight
Periodo de tiempo: Baseline (pre-intervention)
Body weight measured in kilograms
Baseline (pre-intervention)
Body mass index (BMI)
Periodo de tiempo: Baseline (pre-intervention)
Body mass index calculated as kg/m²
Baseline (pre-intervention)
Body composition
Periodo de tiempo: Baseline (pre-intervention)
Fat mass and lean mass measured using DXA
Baseline (pre-intervention)

Colaboradores e Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de marzo de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

17 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

8 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

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

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

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. .

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