New home program aims to boost fitness and function after spinal cord injury
NCT ID NCT03576001
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a home-based program for people with spinal cord injury that combines leg cycling with electrical stimulation, arm exercise, and a hormone treatment. The goal was to see if this combination improves aerobic fitness, daily function, and overall health better than exercise alone. The trial involved 84 adults with cervical or thoracic spinal cord injury who were at least 6 months post-injury.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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84 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA 1. Men and women, 19 to 70 years 2. 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 3. Medically stable, able to follow directions 4. Able to provide informed consent. 5. For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to Day 1 and agreement to use such a method during study participation and for an additional 12 weeks after the end of intervention. EXCLUSION CRITERIA 1. Upper extremity musculoskeletal conditions (such as advanced rotator cuff pathology or carpal tunnel syndrome) or neurological disorder that in the assessment of the study investigator would prevent the participant from performing the prescribed arm ergometry. 2. Current fractures in the upper and lower extremity 3. In accordance with the Endocrine Society and ISSAM Guidelines25,52, we will exclude individuals with a contraindication for androgen use: * History of prostate or breast cancer * Prostate nodule or induration on digital rectal examination (DRE) * Prostate specific antigen (PSA) \> 4 ng/ml or \> 3 ng/ml in individuals at high risk of prostate cancer such as African Americans or those with family history of prostate cancer in first degree relatives, unless there has been a negative prostate biopsy within 3 months * Hematocrit \> 48% 4. Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain. 5. Body mass index (BMI) \> 45 kg/m2 6. Renal dysfunction as indicated by GFR of \<50 ml/min, estimated by using the Modification of Diet in Kidney Disease (MDRD) Study equation, in accordance with K/DOQI guidelines 7. Use of testosterone or other anabolic therapies, including DHEA and androstenedione, or rhGH in the preceding 6 months 8. Active cancer requiring therapy and which may limit life expectancy to less than 5 years 9. Psychosis, bipolar disorder, or major untreated depression 10. Dementia (Mini-Mental Status Exam \[MMSE\] \<24) 11. Myocardial infarction (MI) or stroke within 3 months of entry 12. Pacemaker 13. ALT and AST \> 3 x upper limit of normal 14. Poorly controlled diabetes as indicated by hemoglobin (Hb)-A1c greater than 9.0% or diabetes requiring insulin therapy 15. Blood thinners such as Coumadin, heparin, rivaroxaban (Xarelto), dabigatran (Pradaxa), lovenox (subcutaneous heparin), apixaban (Eliquis) (aspirin, plavix and other anti-platelet agents are allowed) 16. Systolic blood pressure (BP) \> 170 or diastolic BP \> 100 mm Hg 17. Current grade 2 or greater pressure ulcers at relevant contact sites 18. Pressure sores or open wounds on the areas that restricts their participation 19. Because the safety of testosterone has not been established in pregnancy and lactation, we will exclude pregnant or lactating women and women of childbearing potential who are sexually active but are unwilling or unable to use a reliable form of contraception. We will perform a blood test to exclude pregnancy at the time of enrollment. 20. Participation in a structured exercise program currently or in the past 2 months and unwilling to stop the structured exercise program if ongoing at time of screening. Specifically, participation in a structured exercise program, currently or in the past 2 months, that involves progressive resistance exercise training of moderate to high intensity or regular endurance exercise of moderate to high intensity, and unwillingness to stop the structured exercise program if ongoing at time of screening. 21. Inability or unwillingness to participate in the exercise training or the assessments of muscle performance and physical performance
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?