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Testosterone + Hybrid Exercise for Spinal Cord Injury

Boston, MA
Phase 2
Waitlist Available
Led By Shalender Bhasin, MB BS
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women, 19 to 70 years
Confirmed cervical and thoracic, AIS A-D who are at least 6 months post-injury and who use a wheelchair as their primary mobility mode
Must not have
Current grade 2 or greater pressure ulcers at relevant contact sites
Active cancer requiring therapy and which may limit life expectancy to less than 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks

Summary

This trial will test whether a home-based program that includes electrical stimulation during leg cycling, arm ergometry, and an androgen improves function and metabolism more than electrical stimulation during leg cycling and arm ergometry alone.

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Who is the study for?
This trial is for men and women aged 19-70 with spinal cord injury (SCI), at least 6 months post-injury, who primarily use a wheelchair. Participants must be medically stable, able to follow directions, and if female and of reproductive potential, agree to use effective contraception during the study.Check my eligibility
What is being tested?
The trial tests a Home-Based Multimodality Program combining functional electrical stimulation leg cycling with arm ergometry and testosterone against the same exercise program with a placebo. It aims to improve aerobic capacity, function, metabolism, bone health, and wellbeing in SCI patients.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with testosterone therapy such as acne or oily skin, mild fluid retention, stimulation of prostate tissue (with possibly increased urination symptoms), breast enlargement or tenderness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 19 and 70 years old.
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I have a spinal cord injury in my neck or upper back, use a wheelchair, and it's been 6 months since my injury.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe bedsores in areas where my body presses against surfaces.
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My cancer is active and needs treatment, possibly shortening my life to under 5 years.
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My diabetes is poorly controlled, with Hb-A1c over 9% or I need insulin.
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I have no open wounds or pressure sores that would stop me from joining.
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My kidney function is low, with a GFR under 50 ml/min.
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I have a broken bone in my arm or leg.
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I have a lump or hard area in my prostate found during a physical exam.
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I have a history of prostate or breast cancer.
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I do not have severe health issues that make exercise or electrical stimulation unsafe.
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I am pregnant, breastfeeding, or not using birth control while being able to have children.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
peak aerobic capacity achieved during arm ergometry exercise
Secondary study objectives
Anxiety
Chronotropic Index
Loneliness
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Multi-modality intervention groupExperimental Treatment2 Interventions
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Group II: Placebo groupPlacebo Group1 Intervention
Hybrid exercise plus placebo medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone Undecanoate
2014
Completed Phase 4
~410

Find a Location

Closest Location:Brigham and Women's Hospital· Boston, MA

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,692 Previous Clinical Trials
14,788,040 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,101 Previous Clinical Trials
2,760,061 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
142 Previous Clinical Trials
11,077 Total Patients Enrolled
Shalender Bhasin, MB BSPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Hybrid Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03576001 — Phase 2
Spinal Cord Injury Research Study Groups: Multi-modality intervention group, Placebo group
Spinal Cord Injury Clinical Trial 2023: Hybrid Exercise Highlights & Side Effects. Trial Name: NCT03576001 — Phase 2
Hybrid Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03576001 — Phase 2
~13 spots leftby Mar 2026
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