RECRUITING
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Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral leg disuse (Phase 1), immediately followed by 14 days 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.
Conditions:
🦠 Atrophy of Muscle Due to Disuse 🦠 Rehabilitation
🗓️ Study Start (Actual) 27 August 2021
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Galveston, Texas, United States
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 50 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 October 2019
  • First Submitted that Met QC Criteria 1 November 2019
  • First Posted 5 November 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 November 2023
  • Last Update Posted 7 December 2023
  • Last Verified November 2023
I'm interested ...!!