Effect of Knee Position on Muscle Loss During Leg Immobilization
1 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Muscle protein net balance (MPNB)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Thigh muscle volume
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Height
Lasso di tempo: Baseline (pre-intervention)
|
Height measured in meters
|
Baseline (pre-intervention)
|
|
Plasma amino acid concentration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline (pre-intervention)
|
Body weight measured in kilograms
|
Baseline (pre-intervention)
|
|
Body mass index (BMI)
Lasso di tempo: Baseline (pre-intervention)
|
Body mass index calculated as kg/m²
|
Baseline (pre-intervention)
|
|
Body composition
Lasso di tempo: Baseline (pre-intervention)
|
Fat mass and lean mass measured using DXA
|
Baseline (pre-intervention)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 agosto 2026
Completamento primario (Stimato)
1 marzo 2028
Completamento dello studio (Stimato)
1 giugno 2028
Date di iscrizione allo studio
Primo inviato
17 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 luglio 2026
Primo Inserito (Effettivo)
8 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie del sistema nervoso
- Malattie muscolari
- Manifestazioni neuromuscolari
- Condizioni patologiche, anatomiche
- Malattie neuromuscolari
- Atrofia
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Atrofia muscolare
- Disturbi muscolari, atrofico
Altri numeri di identificazione dello studio
- NL010759
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .