Immune Cells During Disuse and Recovery

Not Applicable

Recruiting

• Conditions: Muscle Disuse
• Interventions: Other: Limb immobilization

• Registration Number: NCT04416191
• Lead Sponsor: University of Utah

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.

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 Timeline

• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Study Start: 2022-05-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2027-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Limb immobilization	Limb immobilization	Participants will undergo a 2-week leg immobilization period

Primary Outcome Measures

Name	Time	Method
Thigh Muscle Volume	baseline and after 2 weeks of leg immobilization	change in thigh muscle volume as determined by MRI
Leg Muscle Strength	baseline and after 2 weeks of leg immobilization	change in isometric leg extension strength as determined by a isokinetic dynamometer

Trial Locations

Locations (1)

The University of Utah; 🇺🇸 Salt Lake City, Utah, United States