Muscle DisuseNCT04416191
Immune Cells During Disuse and Recovery
A study testing Limb immobilization in people with Muscle Disuse, run by University of Utah at 1 site in United States.
Trial summary
This is an interventional study enrolling healthy individuals aged 18-35 and 60-85 to understand the recovery of muscle health following a period of inactivity. The enrollment goal is 45 participants. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Disuse
- What is being tested?
- Limb immobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2022to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-35 and 60-85 yrs
- Ability to sign informed consent
- Free-living, prior to admission
Who cannot join
- History of cardiovascular disease (e.g., CHF, CAD, right-to-left shunt)
- History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes
- History of kidney disease or failure
- Vascular disease
- Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III
- Use of anticoagulant therapy (e.g., Coumadin, heparin)
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- Elevated systolic pressure >150 or a diastolic blood pressure > 100
- Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
- Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
- Currently on a weight-loss diet
- Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids are permitted)
- Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement is permitted)
- History of stroke with motor disability
- A recent history (<12 months) of GI bleed
- History of liver disease
- History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
- Pregnancy as determined by a pregnancy test
- Any staff members who report directly to an investigator or who report to someone who reports directly to an investigator.
- Any other condition or event considered exclusionary by the PI and faculty physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Utah
Salt Lake City, Utah, 84112
Micah Drummond, PhD, 8015877764
micah.drummond@hsc.utah.edu
About this study
Official title: Muscle Immune Cells During Disuse and Recovery in Aging and Metabolic Disease
This is an interventional study enrolling healthy individuals aged 18-35 and 60-85 to understand the recovery of muscle health following a period of inactivity. The enrollment goal is 45 participants. The study will occur over the course of 1-2 months where participants will undergo testing before and after a 2-week limb immobilization period.
Read the detailed description
Visit 1 (Pre-testing)- After signing a consent form, participants will undergo a blood screening and an oral glucose tolerance test. After the visit, participants will be provided with a step activity monitor to track their level of activity. A dietary assessment will also be determined.
Visit 2- At a later time, the participant will return to the research center for a biopsy, blood draw, body composition scan, MRI and muscle strength testing.
2-week leg immobilization period- After visit 2 , the participant will return home and undergo a 14-day leg immobilization period using the equipment and instructions provided at visit 2.
Visit 3- During the limb immobilization period, participant will return to the research center for a single blood draw.
Visit 4- At the end of the 2-week limb immobilization period, the participant will return to the research center to undergo another biopsy, blood draw, body composition scan, MRI and muscle strength testing.
Visit 5- 2 days after the 2-week limb immobilization period, the participant will return for a biopsy and blood draw.
Visit 6- 7 days after the 2-week limb immobilization period, the participant will be asked to return for a final biopsy, blood draw, body composition scan, MRI and muscle strength testing.
- Conditions
- Muscle Disuse
- Being tested
- Limb immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb immobilizationOther
Also called Muscle Disuse
Participants will undergo a 2-week period of leg immobilization
| Study group | Role | What they receive |
|---|---|---|
| Limb immobilization | Other | Participants will undergo a 2-week leg immobilization period Receives: Other: Limb immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh Muscle Volume
change in thigh muscle volume as determined by MRI
Measured: baseline and after 2 weeks of leg immobilization
Leg Muscle Strength
change in isometric leg extension strength as determined by a isokinetic dynamometer
Measured: baseline and after 2 weeks of leg immobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 May 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle DisuseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be tested before a 2-week limb immobilization period
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micah Drummond, University of Utah
- Investigators
- Micah Drummond, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416191
- Sponsor's protocol ID
- 130232
- Status last verified
- Dec 2025
- First submitted
- 1 Jun 2020
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan has been put into place
Publications
Skiles CM, Fennel ZJ, Bourrant PE, Yee EM, Castro RJ, Zabriskie HA, Itinose M, Supiano MA, O'Connell RM, Drummond MJ. Robust immune cell infiltration and macrophage senescence occur within a week of recovery after limb immobilization in older adult skeletal muscle. J Physiol. 2026 Apr;604(8):3379-3395. doi: 10.1113/JP290346. Epub 2026 Mar 27.
PubMed 41891949
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Immune Cells During Disuse and Recovery in Aging and Metabolic Disease
- ClinicalTrials.gov ID
- NCT04416191
- Acronym / sponsor ID
- 130232
- Conditions
- Muscle Disuse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Jun 2020 (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 an interventional study enrolling healthy individuals aged 18-35 and 60-85 to understand the recovery of muscle health following a period of inactivity. The enrollment goal is 45 participants. The study will occur over the course of 1-2 months where participants will undergo testing before and after a 2-week limb immobilization period.
Detailed description
Visit 1 (Pre-testing)- After signing a consent form, participants will undergo a blood screening and an oral glucose tolerance test. After the visit, participants will be provided with a step activity monitor to track their level of activity. A dietary assessment will also be determined.
Visit 2- At a later time, the participant will return to the research center for a biopsy, blood draw, body composition scan, MRI and muscle strength testing.
2-week leg immobilization period- After visit 2 , the participant will return home and undergo a 14-day leg immobilization period using the equipment and instructions provided at visit 2.
Visit 3- During the limb immobilization period, participant will return to the research center for a single blood draw.
Visit 4- At the end of the 2-week limb immobilization period, the participant will return to the research center to undergo another biopsy, blood draw, body composition scan, MRI and muscle strength testing.
Visit 5- 2 days after the 2-week limb immobilization period, the participant will return for a biopsy and blood draw.
Visit 6- 7 days after the 2-week limb immobilization period, the participant will be asked to return for a final biopsy, blood draw, body composition scan, MRI and muscle strength testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be tested before a 2-week limb immobilization period
| Arm | Type | Receives |
|---|---|---|
| Limb immobilization | Other | Other: Limb immobilizationParticipants will undergo a 2-week leg immobilization period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-35 and 60-85 yrs
- Ability to sign informed consent
- Free-living, prior to admission
Key exclusion criteria (19 listed)
- History of cardiovascular disease (e.g., CHF, CAD, right-to-left shunt)
- History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes
- History of kidney disease or failure
- Vascular disease
- Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III
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 |
|---|---|---|
| Limb immobilizationAlso: Muscle DisuseParticipants will undergo a 2-week period of leg immobilization | Other | Limb immobilization |
Primary outcome
Thigh Muscle Volume
Time frame: baseline and after 2 weeks of leg immobilization
change in thigh muscle volume as determined by MRI
Leg Muscle Strength
Time frame: baseline and after 2 weeks of leg immobilization
change in isometric leg extension strength as determined by a isokinetic dynamometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Derived from this study: PubMed 41891949Skiles CM, Fennel ZJ, Bourrant PE, Yee EM, Castro RJ, Zabriskie HA, Itinose M, Supiano MA, O'Connell RM, Drummond MJ. Robust immune cell infiltration and macrophage senescence occur within a week of recovery after limb immobilization in older adult skeletal muscle. J Physiol. 2026 Apr;604(8):3379-3395. doi: 10.1113/JP290346. Epub 2026 Mar 27.
- Individual participant dataSharing planned: No. No plan has been put into place
Related trials for Muscle Disuse
Recruiting
Heat Therapy During Reduced Physical Activity
Physical Inactivity, Vascular Dysfunction
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Effect of Knee Position on Muscle Loss During Leg Immobilization
Muscle Atrophy, Disuse Atrophy
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Mitigating Neural Hypoexcitability and Weakness During Disuse in Women
Muscle Weakness
Active, not recruiting
Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
Atrophy of Muscle Due to Disuse, Rehabilitation
Not yet recruiting
Cross-education of Skill and Strength in Healthy People Subjected to an Upper-limb Disuse Model
Disuse Atrophy, Immobilization
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.
Micah Drummond, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limb immobilization in people with Muscle Disuse, run by University of Utah at 1 site in United States.
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 19 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: looking for participants now, as of the sponsor's last update on 5 Dec 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Micah Drummond, PhD (801-213-2737, micah.drummond@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh Muscle Volume (time frame: baseline and after 2 weeks of leg immobilization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416191, which also lists 1 linked publication.
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 5 Dec 2025.