Effect of Knee Position on Muscle Loss During Leg Immobilization

NCT07690150 | Not Yet Recruiting

• 1 other identifier: NL010759
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Muscle Atrophy; Disuse Atrophy; Immobilization

Keywords

Quadriceps; Knee Brace; Muscle Protein Breakdown; Dynamometry; Stable Isotope Tracers; MRI

Outcome Measures

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

  Baseline to 3 hours after tracer infusion

Secondary Outcomes (10)

• Thigh muscle volume

  Baseline and after 5 days of immobilization

• Muscle strength

  Baseline and after 5 days of immobilization

• Muscle fatigue

  Baseline and after 5 days of immobilization

• Intramuscular fat content

  Baseline and after 5 days of immobilization

• Muscle metabolite concentrations

  Baseline and after 5 days of immobilization

Other Outcomes (6)

• Plasma amino acid concentration

  Baseline to 3 hours after tracer infusion

• Serum insulin concentration

  Baseline and up to 3 hours after tracer infusion

• Body weight

  Baseline (pre-intervention)

Study Arms (2)

Neutral Knee Position

ACTIVE COMPARATOR

Participants in this group wear a knee brace in full extension (0°) for five consecutive days.

Device: Knee immobilization brace (0°) for 5 days

Flexed Knee Position

EXPERIMENTAL

Participants in this group wear a knee brace in flexion (60°) for five consecutive days.

Device: Knee immobilization brace (60°) for 5 days

Interventions

Knee immobilization brace (0°) for 5 days DEVICE

Unilateral knee immobilization at 0° flexion for 5 days using a brace; post-immobilization metabolic testing with tracer infusions and biopsies

Neutral Knee Position

Knee immobilization brace (60°) for 5 days DEVICE

Unilateral knee immobilization at 60° flexion for 5 days using a brace; post-immobilization metabolic testing with tracer infusions and biopsies

Flexed Knee Position

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wageningen University: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

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MeSH Terms

Conditions

Muscular Atrophy; Muscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized into two parallel groups: one group wears a knee brace in full extension (0°), and the other in flexion (60°) for five consecutive days. The contralateral leg serves as an internal control. Randomization is stratified by sex and performed in permuted blocks to ensure balanced allocation. There is no masking because the knee position is visible. Both groups undergo identical procedures before and after immobilization, including imaging and metabolic assessments.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07