Effect of Knee Position on Muscle Loss During Leg Immobilization
1 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
30
Faza
- Nie dotyczy
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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
|
|
Eksperymentalny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Muscle protein net balance (MPNB)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Thigh muscle volume
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Height
Ramy czasowe: Baseline (pre-intervention)
|
Height measured in meters
|
Baseline (pre-intervention)
|
|
Plasma amino acid concentration
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline (pre-intervention)
|
Body weight measured in kilograms
|
Baseline (pre-intervention)
|
|
Body mass index (BMI)
Ramy czasowe: Baseline (pre-intervention)
|
Body mass index calculated as kg/m²
|
Baseline (pre-intervention)
|
|
Body composition
Ramy czasowe: Baseline (pre-intervention)
|
Fat mass and lean mass measured using DXA
|
Baseline (pre-intervention)
|
Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 sierpnia 2026
Zakończenie podstawowe (Szacowany)
1 marca 2028
Ukończenie studiów (Szacowany)
1 czerwca 2028
Daty rejestracji na studia
Pierwszy przesłany
17 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 lipca 2026
Pierwszy wysłany (Rzeczywisty)
8 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
8 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NL010759
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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