CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
Testosterone Patches +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01652040
NCT01652040Phase 3Completed

Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury

VA Office of Research and Development·interventional·Posted Jul 27, 2012·Updated May 3, 2018

In Brief

A Phase 3 clinical trial evaluating Resistance Training and Testosterone Patches and Testosterone Patches for Spinal Cord Injury. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2012
Enrollment StartJul 2, 2012
Primary CompletionDec 30, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 13.9 years ago

Interventions

Resistance Training and Testosterone Patchesdevice

We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.

Testosterone Patchesdrug

The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.