SarcopeniaPREHABNCT06205784
Prehabilitative Exercise Prior to Immobilization
A study testing Prehabilitative exercise in people with Sarcopenia and Skeletal Muscle Atrophy, run by Bispebjerg Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Skeletal Muscle Atrophy, Disuse Atrophy
- What is being tested?
- Prehabilitative exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen
Copenhagen, Capital Region, 2400
About this study
Official title: Prehabilitative Exercise - Can the Physiological Consequences of Immobilization be Prevented?
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
- Conditions
- Sarcopenia, Skeletal Muscle Atrophy, Disuse Atrophy
- Being tested
- Prehabilitative exercise
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitative exerciseOther
3-4 weeks of heavy resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Prehab | Experimental | Not described Receives: Other: Prehabilitative exercise |
| NoTrain | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps cross-sectional area
Quadriceps cross-sectional area measured by MRI
Measured: From pre (week 0) to post immobilization (week 5)
Secondary outcomes (12)
Muscle fiber size
Muscle fiber size assessed by histochemical stainings
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Denervated muscle fibers
Assessment denervated fibers using histochemical stainings
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Muscle protein synthesis
Muscle protein synthesis assessed using deuterium (heavy water)
Measured: From pre immobilization (week 4) to post immobilization (week 5)
Muscle gene expression
Muscle gene expression assessed by RNA sequencing
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Brain structure
Brain structure measured by MRI
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Brain function
Brain function measured by MRI
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Tendon structure
Tendon structure measured by MRI
Measured: From pre (week 0) to post immobilization (week 5)
Tendon ultrastructure
Tendon tissue analysed by molecular analyses
Measured: From pre immobilization (week 4) to post immobilization (week 5)
Lean-body mass
Whole-body and thigh lean-body mass assessed using DEXA-scans
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Muscle strength
Muscle strength during knee extension assessed using isokinetic and isometric dynamometers
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Balance
One-legged balanced assessed using a force platform
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Force variability
Force variability during knee extension assessed using submaximal isometric contractions
Measured: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start6 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casper Soendenbroe, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205784
- Sponsor's protocol ID
- BBH164
- Acronym
- PREHAB
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitative Exercise - Can the Physiological Consequences of Immobilization be Prevented?
- ClinicalTrials.gov ID
- NCT06205784
- Acronym / sponsor ID
- PREHAB / BBH164
- Conditions
- Sarcopenia, Skeletal Muscle Atrophy, Disuse Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehab | Experimental | Other: Prehabilitative exercise |
| NoTrain | No intervention | – |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitative exercise3-4 weeks of heavy resistance exercise | Other | Prehab |
Primary outcome
Quadriceps cross-sectional area
Time frame: From pre (week 0) to post immobilization (week 5)
Quadriceps cross-sectional area measured by MRI
12 secondary outcomes
Muscle fiber size
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Denervated muscle fibers
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Muscle protein synthesis
Time frame: From pre immobilization (week 4) to post immobilization (week 5)
Muscle gene expression
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Brain structure
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Brain function
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Tendon structure
Time frame: From pre (week 0) to post immobilization (week 5)
Tendon ultrastructure
Time frame: From pre immobilization (week 4) to post immobilization (week 5)
Lean-body mass
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Muscle strength
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Balance
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Force variability
Time frame: From pre (week 0) to post immobilization (week 5) and post retraining (week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitative exercise in people with Sarcopenia and Skeletal Muscle Atrophy, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps cross-sectional area (time frame: From pre (week 0) to post immobilization (week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.