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Testosterone + Hybrid Exercise for Spinal Cord Injury
Phase 2
Recruiting
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
Awards & highlights
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.
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.
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.
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 belowSelect...
I am between 19 and 70 years old.
Select...
I have a spinal cord injury in my neck or upper back, use a wheelchair, and it's been 6 months since my injury.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe bedsores in areas where my body presses against surfaces.
Select...
My cancer is active and needs treatment, possibly shortening my life to under 5 years.
Select...
My diabetes is poorly controlled, with Hb-A1c over 9% or I need insulin.
Select...
I have no open wounds or pressure sores that would stop me from joining.
Select...
My kidney function is low, with a GFR under 50 ml/min.
Select...
I have a broken bone in my arm or leg.
Select...
I have a lump or hard area in my prostate found during a physical exam.
Select...
I have a history of prostate or breast cancer.
Select...
I do not have severe health issues that make exercise or electrical stimulation unsafe.
Select...
I am pregnant, breastfeeding, or not using birth control while being able to have children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Anxiety
Loneliness
Mood
+6 moreTrial 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
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,490,951 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,750 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
137 Previous Clinical Trials
10,933 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently doing a regular exercise program and are not willing to stop it for the study.My PSA level is above 4 ng/ml, or above 3 ng/ml due to my high risk of prostate cancer.Your liver enzymes ALT and AST are more than three times the normal level.Your blood pressure is very high, with the top number (systolic) over 170 or the bottom number (diastolic) over 100.I am not taking blood thinners like Coumadin or Xarelto, but aspirin is okay.I have severe bedsores in areas where my body presses against surfaces.I have not used testosterone, DHEA, androstenedione, or rhGH in the last 6 months.I don't have arm conditions that would stop me from doing specific arm exercises.My cancer is active and needs treatment, possibly shortening my life to under 5 years.My diabetes is poorly controlled, with Hb-A1c over 9% or I need insulin.I am between 19 and 70 years old.I am medically stable and can follow instructions.Your hematocrit level is higher than 48%.You have significant memory and thinking problems, as shown by a test called the Mini-Mental Status Exam.You have severe mental health conditions like psychosis, bipolar disorder, or untreated major depression.I have no open wounds or pressure sores that would stop me from joining.I have not had a heart attack or stroke in the last 3 months.You have a pacemaker.Your body mass index (BMI) is higher than 45.My kidney function is low, with a GFR under 50 ml/min.I have a broken bone in my arm or leg.I have a lump or hard area in my prostate found during a physical exam.I have a history of prostate or breast cancer.I do not have severe health issues that make exercise or electrical stimulation unsafe.I have a spinal cord injury in my neck or upper back, use a wheelchair, and it's been 6 months since my injury.I am pregnant, breastfeeding, or not using birth control while being able to have children.
Research Study Groups:
This trial has the following groups:- Group 1: Multi-modality intervention group
- Group 2: Placebo group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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