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Resistance Training and Testosterone After Spinal Cord Injury

NCT01652040 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-05-03

Study results available
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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.

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

Resistance Training and Testosterone Patches

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.

DRUG

Testosterone Patches

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

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ashraf Gorgey, PhD PT · Hunter Holmes McGuire VA Medical Center, Richmond, VA

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-02
Primary Completion
2017-12-30
Completion
2017-12-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01652040 on ClinicalTrials.gov