RECRUITING

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

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Conditions

Atrophy of Muscle Due to DisuseRehabilitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-08-27
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04151901

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.

Ages Eligible for Study:50 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. All races and ethnic backgrounds
  2. 2. Men and women, age 50-65 years
  3. 3. Generally healthy (see exclusion criteria)
  4. 4. Able and willing to provide informed consent
  5. 5. Ability to speak and read English
  6. 6. Post-menopausal women (no menses within the last 12 months)
  7. 7. Body mass index: 18.5-35 kg/m2 or BMI\>35 if thigh adiposity does not impair muscle biopsy
  1. 1. Compromised musculoskeletal function that precludes safe participation or use of crutches
  2. 2. Pre-menopausal women
  3. 3. Hypogonadal men (testosterone \<300 ng/dL)
  4. 4. Women taking hormone replacement therapy (HRT)
  5. 5. Sarcopenia (European Working Group on Sarcopenia in Older People, EWGSOP102)
  6. 6. Clinically significant heart disease (e.g. New York Heart Classification greater than grade II; ischemia)
  7. 7. Peripheral vascular disease
  8. 8. History of claudication
  9. 9. Pulmonary disease
  10. 10. History of systemic or pulmonary embolus
  11. 11. Uncontrolled blood pressure (systolic BP\>170, diastolic BP\>95 mmHg)
  12. 12. Impaired renal function (creatinine \>1.5 mg/dl)
  13. 13. Anemia (hematocrit \<33)
  14. 14. Untreated thyroid disease (abnormal TSH)
  15. 15. A recent history (\<12 months) of GI bleed
  16. 16. Diabetes mellitus or other untreated endocrine or metabolic disease
  17. 17. Electrolyte abnormalities
  18. 18. Any history of stroke, hypo- or hyper-coagulation disorders
  19. 19. Employment requiring long (\>1 h) uninterrupted period of standing
  20. 20. Inability to meet study travel requirements (e.g. manual geared car)
  21. 21. Recent history of balance issues or falls.
  22. 22. Recent (3 years) treated cancer other than basal cell carcinoma
  23. 23. Systemic steroids, anabolic steroids, growth hormone or immunosuppressant use within 12 months
  24. 24. Recent (2 months) adherence to a weight-loss or weight-gain diet
  25. 25. Weight change of 5% or more in previous 6 months
  26. 26. Body mass index \>30 or excess body fat that compromises muscle biopsy collection
  27. 27. Acute infectious disease or chronic infection
  28. 28. Alcohol or drug abuse
  29. 29. Any other condition or event considered exclusionary by study physician

Contacts and Locations

Study Contact

Blake Rasmussen, PhD
CONTACT
210-450-7491
rasmussenb@uthscsa.edu
Sean Kilroe, PhD
CONTACT
kilroe@uthscsa.edu

Principal Investigator

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

Study Locations (Sites)

University of Texas Medical Branch
Galveston, Texas, 77555
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: 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

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

Study Start Date2021-08-27
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-08-27
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Atrophy of Muscle Due to Disuse
  • Rehabilitation