NCT06205784

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

January 6, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

December 19, 2023

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quadriceps cross-sectional area

    Quadriceps cross-sectional area measured by MRI

    From pre (week 0) to post immobilization (week 5)

Secondary Outcomes (12)

  • 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 protein synthesis

    From pre immobilization (week 4) to post immobilization (week 5)

  • Muscle gene expression

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

  • Brain structure

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

  • +7 more secondary outcomes

Study Arms (2)

Prehab

EXPERIMENTAL
Other: Prehabilitative exercise

NoTrain

NO INTERVENTION

Interventions

3-4 weeks of heavy resistance exercise

Prehab

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen, Capital Region, 2400, Denmark

Location

MeSH Terms

Conditions

SarcopeniaMuscular AtrophyMuscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 16, 2024

Study Start

January 6, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations