Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Part of paid clinical trials in Gainesville, Florida.

Sponsor
North Florida Foundation for Research and Education
Study ID
NCT04460872
Phase
PHASE2
Status
Recruiting
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Conditions

  • Androgen Deficiency
  • Central Nervous System Diseases
  • Endocrine System Diseases
  • Gait Disorders, Neurologic
  • Genital Diseases, Male
  • Gonadal Disorders
  • Hormone Deficiency
  • Hypogonadism
  • Injuries, Spinal Cord
  • Locomotion Disorder, Neurologic
  • Nervous System Diseases
  • Spinal Cord Diseases
  • Spinal Cord Injuries
  • Spinal Cord Injury
  • Spinal Cord Trauma
  • Testosterone Deficiency
  • Trauma, Nervous System
  • Walking, Difficulty
  • Wounds and Injuries
  • Wounds and Injury

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Testosterone Enanthate — DRUG
    Subjects receive testosterone (100 mg/week) by intramuscular injection
  • Locomotor Training — BEHAVIORAL
    Subjects receive locomotor training (4 sessions/week for 2-3 months)

Study Details

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

Key Dates

Start date
Jan 31, 2021
Status verified
May 2025
Primary completion
Jan 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: testosterone enanthate
    Testosterone enanthate via i.m. injection (100 mg/week)
  • Experimental: locomotor training, testosterone enanthate
    Treadmill and overground walking training and testosterone enanthate via i.m. injection (100 mg/week)
  • No Intervention: non-interventional control
    Non-interventional control group

Primary Outcome Measure

change in thigh muscle cross-sectional area [ Time Frame: baseline, 3 months, 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
North Florida/South Georgia Veterans Health SystemGainesvilleFlorida32608
Dana M Otzel, PhD
[email protected]
(352) 548-6477
Joshua F Yarrow, PhD
[email protected]
Brooks RehabilitationJacksonvilleFlorida32216
Emily J Fox, DPT, PhD
[email protected]
(352) 273-6117

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North Florida/South Georgia Veterans Health System· Gainesville, FLBrooks Rehabilitation· Jacksonville, FL

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