Clinical trial NCT06205784: Prehabilitative Exercise Prior to Immobilization
Official title: Prehabilitative Exercise - Can the Physiological Consequences of Immobilization be Prevented?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Skeletal Muscle Atrophy
Disuse Atrophy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Quadriceps cross-sectional area
timeFrame: From pre (week 0) to post immobilization (week 5)
Secondary outcomes:
measure: Muscle fiber size
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Denervated muscle fibers
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Muscle protein synthesis
timeFrame: From pre immobilization (week 4) to post immobilization (week 5)
measure: Muscle gene expression
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Brain structure
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Brain function
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Tendon structure
timeFrame: From pre (week 0) to post immobilization (week 5)
measure: Tendon ultrastructure
timeFrame: From pre immobilization (week 4) to post immobilization (week 5)
measure: Lean-body mass
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Muscle strength
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Balance
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
measure: Force variability
timeFrame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
state: Capital Region
Study officials:
References: