Phase 3
N=26
Resistance Training and Testosterone After Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01652040 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Body Composition — 31.84; 33.4; 30.75; 32.12 percentage of fat mass
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Resistance Training and Testosterone Patches (Device); Testosterone Patches (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Composition |
31.84; 33.4; 30.75; 32.12 | — |
| SECONDARY Metabolic Profile |
1525; 1491; 1665; 1502 | — |
Summary
The goal of this proposal is to investigate the efficacy of a complimentary approach of evoked resistance training and testosterone replacement therapy on the changes in body composition and metabolic profile after SCI. The proposed method could become a recommended and simple intervention especially for individuals with limited access and poor tolerance to exercise. The rationale is based on the evidence that individuals with SCI experience decline in anabolic hormones which may be responsible for the deterioration in body composition and metabolic profiles and leads to increase obesity, type 2 diabetes mellitus, dyslipidemia and subsequently cardiovascular disease. The designed study will provide explanation to the adaptations in the energy source of the muscle cells in response to training.
Eligibility Criteria
Inclusion Criteria
- Male with Spinal Cord Injury
- Between 18-50 years old
- BMI < 30 Kg/m2
- Traumatic motor complete C5-L2 level of injury
- American Spinal Injury Classification (A and B; i.e. motor deficit below the level of injury)
Exclusion Criteria
- Cardiovascular disease
- Uncontrolled type II DM and those on insulin
- Pressures sores stage 2 or greater
- Supra-physiological T level
- Hematocrit above 50%
- Urinary tract infection or symptoms
Data sourced from ClinicalTrials.gov (NCT01652040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.