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RECRUITING

NCT04151901

Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral leg disuse (Phase 1), immediately followed by 1 week of bilateral leg rehabilitation (Phase 2). The investigators will recruit cohorts of healthy middle-aged men and women to address their aims: * Demonstrate the sex-specific effects of skeletal muscle disuse (Phase 1) * Identify key molecular determinates of susceptibility of skeletal muscle atrophy (Phase 1) * Map the early, sex-specific molecular time-course of rehabilitation (Phase 2) * Determine if disused and healthy muscle respond similarly to exercise (Phase 2) Healthy, middle-age men and post-menopausal women (50-65 years) will be recruited from the greater Houston/Galveston area. This under-represented research demographic demonstrate few negative metabolic or phenotypic signs of advanced age, but are at increased risk of being hospitalized and experiencing accelerated loss of lean mass and muscle function that parallels a much older population. The goal of this study is to characterize phenotypic and molecular skeletal muscle changes in middle-aged men and women during critical periods of disuse and rehabilitation and ultimately direct the development of targeted and effective prevention and treatment strategies.

Key Details

Gender

All

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-08-27

Completion Date

2026-12

Last Updated

2026-01-28

Healthy Volunteers

Yes

Conditions

Atrophy of Muscle Due to Disuse Rehabilitation

Interventions

OTHER

Resistance Exercise Rehabilitation

Following disuse, the REHAB groups (M-REHAB, F-REHAB) will complete monitored resistance exercise rehabilitation sessions using an isokinetic dynamometer at a similar relative load at each rehab visit.

OTHER

Walking-based rehabilitation

Following disuse, the CON groups (M-CON, F-CON) will complete 30 minutes of monitored walking at a moderate intensity at each rehab visit.

Inclusion Criteria: 1. All races and ethnic backgrounds 2. Men and women, age 50-65 years 3. Generally healthy (see exclusion criteria) 4. Able and willing to provide informed consent 5. Ability to speak and read English 6. Post-menopausal women (no menses within the last 12 months) 7. Body mass index: 18.5-35 kg/m2 or BMI\>35 if thigh adiposity does not impair muscle biopsy Exclusion Criteria: 1. Compromised musculoskeletal function that precludes safe participation or use of crutches 2. Pre-menopausal women 3. Hypogonadal men (testosterone \<300 ng/dL) 4. Women taking hormone replacement therapy (HRT) 5. Sarcopenia (European Working Group on Sarcopenia in Older People, EWGSOP102) 6. Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia) 7. Peripheral vascular disease 8. History of claudication 9. Pulmonary disease 10. History of systemic or pulmonary embolus 11. Uncontrolled blood pressure (systolic BP\>170, diastolic BP\>95 mmHg) 12. Impaired renal function (creatinine \>1.5 mg/dl) 13. Anemia (hematocrit \<33) 14. Untreated thyroid disease (abnormal TSH) 15. A recent history (\<12 months) of GI bleed 16. Diabetes mellitus or other untreated endocrine or metabolic disease 17. Electrolyte abnormalities 18. Any history of stroke, hypo- or hyper-coagulation disorders 19. Employment requiring long (\>1 h) uninterrupted period of standing 20. Inability to meet study travel requirements (e.g. manual geared car) 21. Recent history of balance issues or falls. 22. Recent (3 years) treated cancer other than basal cell carcinoma 23. Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within 12 months 24. Recent (2 months) adherence to a weight-loss or weight-gain diet 25. Weight change of 5% or more in previous 6 months 26. Body mass index \>30 or excess body fat that compromises muscle biopsy collection 27. Acute infectious disease or chronic infection 28. Alcohol or drug abuse 29. Any other condition or event considered exclusionary by study physician

Locations (2)

University of Texas Medical Branch

Galveston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States