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NCT Number: NCT04416191

Immune Cells During Disuse and Recovery

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.

Recruiting

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Utah

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Micah Drummond

PRINCIPAL_INVESTIGATOR

Micah Drummond, PhD

CONTACT

8015877764

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-35 and 60-85 yrs
  • Ability to sign informed consent
  • Free-living, prior to admission

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

Treatment and study plan

Limb immobilization

Other

Participants will undergo a 2-week period of leg immobilization

Other names: Muscle Disuse

Primary outcomes

  1. Thigh Muscle Volume

    Time frame: baseline and after 2 weeks of leg immobilization

    change in thigh muscle volume as determined by MRI

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Micah Drummond, PhD

CONTACT

[email protected]

801-213-2737

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Muscle Immune Cells During Disuse and Recovery in Aging and Metabolic Disease

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jun 4, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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