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

NCT04151901 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-28

No results posted yet for this study

Summary

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

Interventions

OTHER

Resistance Exercise Rehabilitation

Following disuse, the REHAB groups (M-REHAB, F-REHAB) will complete monitored resistance exercise rehabilitation sessions using an isokinetic dynamometer at a similar relative load at each rehab visit.

OTHER

Walking-based rehabilitation

Following disuse, the CON groups (M-CON, F-CON) will complete 30 minutes of monitored walking at a moderate intensity at each rehab visit.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2026-04-30
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04151901 on ClinicalTrials.gov