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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
Medically stable, able to follow directions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study 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.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 am medically stable and can follow instructions.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
peak aerobic capacity
Secondary outcome measures
Anxiety
Loneliness
Mood
+6 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
~390

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,602 Previous Clinical Trials
11,463,137 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,660,392 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
133 Previous Clinical Trials
10,935 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent have hybrid exercise studies been explored previously?

"Presently, there are 8 trials researching hybrid exercise. None of these experiments have advanced to the third and final stage. Although Boston, Massachusetts is a hub for such investigations, across 46 other sites clinical studies on this therapy are being conducted."

Answered by AI

Are there any openings available for this experimental program?

"According to the most recent records available on clinicaltrials.gov, recruitment for this trial is ongoing. It was initially posted in late August 2019 and its information has been updated as recently as July 11th 2021."

Answered by AI

What potential hazards could arise from hybrid physical activities?

"Hybrid exercise is estimated to be relatively safe, so it was assigned a score of 2. This rating indicates that while the data supports safety, there is yet insufficient evidence for efficacy."

Answered by AI

How many participants have been enrolled to receive this experimental treatment?

"Affirmative. According to clinicaltrials.gov, the research project posted on August 23rd 2019 is presently enrolling patients. A total of 88 participants are sought from a single medical centre."

Answered by AI

Are septuagenarians eligible to partake in this investigation?

"The requirements for enrollment in this trial necessitate that patients be between 19 and 70 years old. For individuals outside of this age range, there are 37 studies available to those younger than 18 as well as 311 trials catering to the elderly."

Answered by AI

Are there particular demographic criteria for participation in this trial?

"This clinical study is currently admitting 88 individuals with spinal cord injuries between the ages of 19 and 70. In order to be considered for enrollment, applicants must meet specific requirements such as: Women of reproductive age who are sexually active must agree to use highly effective contraception for at least one month prior to Day 1 and continue usage during participation in the trial and an additional 12 weeks following intervention; Men or women aged 19-70 years diagnosed with cervical and thoracic AIS grades A-D who primarily rely on a wheelchair for mobility; Stable health status; Ability to abide by instructions provided throughout the study, As well as providing informed consent prior"

Answered by AI
~12 spots leftby Dec 2024