Investigating how sex affects recovery from muscle disuse
Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
This study tests how being male or female affects recovery from muscle loss after not using one leg for a week, focusing on healthy middle-aged adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 2 sites (Galveston, Texas and 1 other locations) |
| Trial ID | NCT04151901 on ClinicalTrials.gov |
What this trial studies
This project involves a two-phase randomized clinical trial where participants undergo 7 days of unilateral leg disuse followed by 1 week of bilateral leg rehabilitation. The study aims to explore sex-specific effects of muscle disuse and identify molecular determinants of susceptibility to muscle atrophy. It will also map the early molecular responses to rehabilitation in both men and post-menopausal women. The trial focuses on healthy middle-aged individuals to better understand the risks associated with muscle disuse and recovery.
Who should consider this trial
Good fit: Ideal candidates are healthy middle-aged men and post-menopausal women aged 50-65 years.
Not a fit: Patients with significant musculoskeletal issues or those on hormone replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored rehabilitation strategies that improve recovery outcomes for individuals at risk of muscle disuse.
How similar studies have performed: While there is existing research on muscle disuse and recovery, this study's focus on sex-specific determinants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Galveston, Texas and 1 other locations
- University of Texas Medical Branch — Galveston, Texas, United States (Completed)
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Blake Rasmussen, PhD — University of Texas Health Science Center as San Antonio
- Study coordinator: Blake Rasmussen, PhD
- Email: rasmussenb@uthscsa.edu
- Phone: 210-450-7491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.