Immune Cells During Disuse and Recovery

Utah System of Higher Education (USHE)

Status

Enrolling

Conditions

Muscle Disuse

Treatments

Other: Limb immobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT04416191

130232

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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