Immune Cells During Disuse and Recovery

NCT04416191 | Recruiting DMC

• 1 other identifier: 130232
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Disuse

Outcome Measures

Primary Outcomes (2)

• Thigh Muscle Volume

  change in thigh muscle volume as determined by MRI

  baseline and after 2 weeks of leg immobilization

• Leg Muscle Strength

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

  baseline and after 2 weeks of leg immobilization

Study Arms (1)

Limb immobilization

OTHER

Participants will undergo a 2-week leg immobilization period

Other: Limb immobilization

Interventions

Limb immobilization OTHER

Participants will undergo a 2-week period of leg immobilization

Also known as: Muscle Disuse

Limb immobilization

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

The University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Study Officials

• Micah Drummond, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Micah Drummond, PhD

CONTACT

801-213-2737; micah.drummond@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be tested before a 2-week limb immobilization period

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: May 15, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)