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Clinical Trials/NCT06205784
NCT06205784
Completed
N/A

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

Bispebjerg Hospital1 site in 1 country64 target enrollmentJanuary 6, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Bispebjerg Hospital
Enrollment
64
Locations
1
Primary Endpoint
Quadriceps cross-sectional area
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 6, 2024
End Date
June 1, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Casper Soendenbroe

Postdoc

Bispebjerg Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • More than one muscle biopsy previously taken from both vastus lateralis muscles.
  • 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.

Outcomes

Primary Outcomes

Quadriceps cross-sectional area

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

Quadriceps cross-sectional area measured by MRI

Secondary Outcomes

  • Brain structure(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Lean-body mass(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Muscle strength(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Muscle fiber size(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Denervated muscle fibers(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Muscle gene expression(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Tendon ultrastructure(From pre immobilization (week 4) to post immobilization (week 5))
  • Muscle protein synthesis(From pre immobilization (week 4) to post immobilization (week 5))
  • Tendon structure(From pre (week 0) to post immobilization (week 5))
  • Balance(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Force variability(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))
  • Brain function(From pre (week 0) to post immobilization (week 5) and post retraining (week 10))

Study Sites (1)

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