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RecruitingNCT04416191Updated Dec 5, 2025

Immune Cells During Disuse and Recovery

An interventional study of Limb immobilization in Muscle Disuse, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by University of Utah · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Muscle Disuse
03

In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age between 18-35 and 60-85 yrs
  2. Ability to sign informed consent
  3. Free-living, prior to admission

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Other
    Limb immobilization

    Participants will undergo a 2-week leg immobilization period

    Other: Limb immobilization

Interventions

  • OtherLimb immobilization

    Participants will undergo a 2-week period of leg immobilization

    Also known as: Muscle Disuse

06

What researchers measure

Primary outcomes

  1. Thigh Muscle Volume

    change in thigh muscle volume as determined by MRI

    Time frame: baseline and after 2 weeks of leg immobilization

  2. Leg Muscle Strength

    change in isometric leg extension strength as determined by a isokinetic dynamometer

    Time frame: baseline and after 2 weeks of leg immobilization

07

Study locations

1 of 1 sites recruiting
  • The University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — No plan has been put into place

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04416191
Lead sponsor
University of Utah
Responsible party
Micah Drummond (Associate Professor, University of Utah) — Principal investigator
First posted
Jun 4, 2020
Start date
May 15, 2022
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Dec 5, 2025

Study contacts

Micah Drummond, PhD
Contact
micah.drummond@hsc.utah.edu
801-213-2737
Micah Drummond, PhD
principal investigator · University of Utah

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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