Prehabilitative Exercise Prior to Immobilization

Sarcopenia Clinical Trial

— PREHAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205784
• Other study ID #: BBH164
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2024
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Disuse Atrophy
• Muscular Atrophy
• Muscular Disorders, Atrophic
• Sarcopenia
• Skeletal Muscle Atrophy

Intervention

Other:
• Prehabilitative exercise
3-4 weeks of heavy resistance exercise

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps cross-sectional area	Quadriceps cross-sectional area measured by MRI	From pre (week 0) to post immobilization (week 5)
Secondary	Muscle fiber size	Muscle fiber size assessed by histochemical stainings	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Denervated muscle fibers	Assessment denervated fibers using histochemical stainings	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Muscle protein synthesis	Muscle protein synthesis assessed using deuterium (heavy water)	From pre immobilization (week 4) to post immobilization (week 5)
Secondary	Muscle gene expression	Muscle gene expression assessed by RNA sequencing	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Brain structure	Brain structure measured by MRI	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Brain function	Brain function measured by MRI	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Tendon structure	Tendon structure measured by MRI	From pre (week 0) to post immobilization (week 5)
Secondary	Tendon ultrastructure	Tendon tissue analysed by molecular analyses	From pre immobilization (week 4) to post immobilization (week 5)
Secondary	Lean-body mass	Whole-body and thigh lean-body mass assessed using DEXA-scans	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Muscle strength	Muscle strength during knee extension assessed using isokinetic and isometric dynamometers	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Balance	One-legged balanced assessed using a force platform	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Secondary	Force variability	Force variability during knee extension assessed using submaximal isometric contractions	From pre (week 0) to post immobilization (week 5) and post retraining (week 10)