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Completed

NCT Number: NCT06205784

Prehabilitative Exercise Prior to Immobilization

This is a 10-week human study involving 24 younger (20-35 y) and 24 older (65-85 y) healthy individuals. All participants will undergo unilateral immobilization of a knee for 7-10 days, followed by 4 weeks of heavy resistance exercise training (HReT). Half of the participants (12 younger and 12 older) will also undergo 4 weeks HReT prior to the immobilization. Prehabilitative exercise may confer protective effects on subsequent immobilization, and the various underlying mechanisms involved

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Key information

Conditions

Sarcopenia Atrophy Disuse Atrophy Muscular Atrophy Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Skeletal Muscle Atrophy

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen

Copenhagen, Capital Region, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: Between 20-35 years old or between 65-85 years old.
  • BMI: Between 18.5 and 35 kg/m2.
  • Healthy and well, with normal dietary habits (not vegan).

Exclusion criteria

  • More than one muscle biopsy previously taken from both vastus lateralis muscles.
  • Smoking.
  • Pregnancy.
  • Past or present substance or alcohol abuse.
  • Medical/surgical conditions that are assessed to affect protein synthesis or the participant's involvement in the trial.
  • Knee pain that could affect the completion of the training intervention.
  • High intake of supplements that increase the risk of bleeding during muscle biopsy (such as fish oil and ginger).
  • Participation in regular strength training within the past year.
  • Regular participation in structured sports.
  • Current use of blood-thinning medication.
  • Previous participation in trials involving oral intake of heavy water.
  • Metal in the body preventing MRI scanning.
  • For the older group, not having gone through menopause, and for the younger group, not having a regular menstrual cycle.

Treatment and study plan

Prehabilitative exercise

Other

3-4 weeks of heavy resistance exercise

Primary outcomes

  1. Quadriceps cross-sectional area

    Time frame: From pre (week 0) to post immobilization (week 5)

    Quadriceps cross-sectional area measured by MRI

Secondary outcomes

  1. Muscle fiber size

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Muscle fiber size assessed by histochemical stainings

  2. Denervated muscle fibers

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Assessment denervated fibers using histochemical stainings

  3. Muscle protein synthesis

    Time frame: From pre immobilization (week 4) to post immobilization (week 5)

    Muscle protein synthesis assessed using deuterium (heavy water)

  4. Muscle gene expression

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Muscle gene expression assessed by RNA sequencing

  5. Brain structure

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Brain structure measured by MRI

  6. Brain function

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Brain function measured by MRI

  7. Tendon structure

    Time frame: From pre (week 0) to post immobilization (week 5)

    Tendon structure measured by MRI

  8. Tendon ultrastructure

    Time frame: From pre immobilization (week 4) to post immobilization (week 5)

    Tendon tissue analysed by molecular analyses

  9. Lean-body mass

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Whole-body and thigh lean-body mass assessed using DEXA-scans

  10. Muscle strength

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Muscle strength during knee extension assessed using isokinetic and isometric dynamometers

  11. Balance

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    One-legged balanced assessed using a force platform

  12. Force variability

    Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)

    Force variability during knee extension assessed using submaximal isometric contractions

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Prehabilitative Exercise - Can the Physiological Consequences of Immobilization be Prevented?

Acronym: PREHAB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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