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Testosterone + Hybrid Exercise for Spinal Cord Injury
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Multi-modality intervention group
- Group 2: Placebo group
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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"
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