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

Description

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.

Conditions

Atrophy of Muscle Due to Disuse, Rehabilitation

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Atrophy of Muscle Due to Disuse
Intervention / Treatment

-

Contacts and Locations

Galveston

University of Texas Medical Branch, Galveston, Texas, United States, 77555

San Antonio

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Blake Rasmussen, PhD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center as San Antonio

Study Record Dates

2026-12