Effect of Knee Position on Muscle Loss During Leg Immobilization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorWageningen University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Knee immobilization brace (0°) for 5 days
DeviceUnilateral knee immobilization at 0° flexion for 5 days using a brace; post-immobilization metabolic testing with tracer infusions and biopsies
Knee immobilization brace (60°) for 5 days
DeviceUnilateral knee immobilization at 60° flexion for 5 days using a brace; post-immobilization metabolic testing with tracer infusions and biopsies
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Neutral Knee PositionActive comparator 1 intervention
Group B: Flexed Knee PositionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Muscle protein net balance (MPNB)
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
Time frame
Baseline to 3 hours after tracer infusionSecondary outcomes
1
Thigh muscle volume
Thigh muscle volume, including muscle length and cross-sectional area, measured via Magnetic Resonance Imaging (MRI)
Time frame
Baseline and after 5 days of immobilization2
Muscle strength
Maximal voluntary muscle strength measured as peak torque using isokinetic dynamometry
Time frame
Baseline and after 5 days of immobilization3
Muscle fatigue
Muscle fatigue assessed as decline in force during repeated contractions measured using isokinetic dynamometry
Time frame
Baseline and after 5 days of immobilization4
Intramuscular fat content
Intramuscular lipid content measured using 1H-magnetic resonance spectroscopy (1H-MRS)
Time frame
Baseline and after 5 days of immobilizationOther outcomes
1
Plasma amino acid concentration
Plasma concentration of amino acids measured in venous blood samples
Time frame
Baseline to 3 hours after tracer infusion2
Serum insulin concentration
Serum insulin concentration measured in venous blood samples
Time frame
Baseline and up to 3 hours after tracer infusion3
Body weight
Body weight measured in kilograms
Time frame
Baseline (pre-intervention)4
Height
Height measured in meters
Time frame
Baseline (pre-intervention)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wageningen University
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: