Actively Recruiting

Phase Not Applicable
Age: 50Years - 65Years
All Genders
Healthy Volunteers
NCT04151901

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

Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-01-28

80

Participants Needed

2

Research Sites

274 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center at San Antonio

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 50 to 65 years
  • Generally healthy individuals
  • Able and willing to provide informed consent
  • Ability to speak and read English
  • Post-menopausal women (no menstrual periods in the last 12 months)
  • Body mass index between 18.5 and 35 kg/m2, or BMI over 35 if thigh fat does not interfere with muscle biopsy
Not Eligible

You will not qualify if you...

  • Musculoskeletal problems preventing safe participation or use of crutches
  • Pre-menopausal women
  • Men with low testosterone levels (less than 300 ng/dL)
  • Women taking hormone replacement therapy
  • Sarcopenia diagnosed by standard criteria
  • Significant heart disease (New York Heart Classification over grade II, ischemia)
  • Peripheral vascular disease or history of claudication
  • Lung diseases or history of embolism
  • Uncontrolled high blood pressure (systolic over 170 or diastolic over 95 mmHg)
  • Poor kidney function (creatinine over 1.5 mg/dl)
  • Anemia (hematocrit less than 33)
  • Untreated thyroid disease
  • Recent gastrointestinal bleeding (within 12 months)
  • Diabetes or other untreated endocrine or metabolic diseases
  • Electrolyte imbalances
  • History of stroke or blood clotting disorders
  • Jobs requiring standing for longer than 1 hour without breaks
  • Inability to meet travel requirements
  • Recent balance problems or falls
  • Cancer treated within the past 3 years except basal cell carcinoma
  • Use of systemic steroids, anabolic steroids, growth hormone, or immunosuppressants within 12 months
  • Recent weight-loss or weight-gain diet adherence (within 2 months)
  • Weight change of 5% or more in the last 6 months
  • Body mass index over 30 or excess body fat that affects muscle biopsy
  • Acute or chronic infections
  • Alcohol or drug abuse
  • Any other condition deemed exclusionary by the study doctor

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Completed

2

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

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Research Team

B

Blake Rasmussen, PhD

CONTACT

S

Sean Kilroe, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

OTHER

Number of Arms

4

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