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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Nov 1, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how muscle loss from not using our legs affects men and women differently, and how they recover once they start exercising again. Over a total of 21 days, participants will go through two phases: first, they will not use one leg for seven days, and then they will do rehabilitation exercises for both legs for two weeks. The researchers aim to understand the changes that occur in muscle during both disuse and rehabilitation, which could help create better treatments for muscle loss in people as they age.

The study is looking for healthy men and women between the ages of 50 and 65 from the Houston/Galveston area. To participate, individuals need to be generally healthy, able to provide informed consent, and able to speak and read English. Certain health conditions, like significant heart issues or recent cancer treatment, may prevent someone from joining. Participants can expect to engage in a structured program that will help researchers learn more about muscle health, which could lead to improved strategies for maintaining muscle strength in older adults.

Gender

ALL

Eligibility criteria

• 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