New home program aims to boost fitness and function after spinal cord injury

NCT ID NCT03576001

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Started

Aug 2019

Finished

Mar 2025

Lead sponsor

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

19 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

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Other studies related to the condition(s) this trial covers.