Spinal Cord InjuriesPhase 2NCT03576001
Multimodality Intervention for Function and Metabolism in SCI
A Phase 2 study testing Testosterone Undecanoate and hybrid exercise in people with Spinal Cord Injuries, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Testosterone Undecanoate and hybrid exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 30 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Medically stable, able to follow directions
- Able to provide informed consent.
- 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.
Who cannot join
- 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.
- Current fractures in the upper and lower extremity
- 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
Show all 25Show fewer
- Hematocrit > 48%
- Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain.
- Body mass index (BMI) > 45 kg/m2
- 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
- Use of testosterone or other anabolic therapies, including DHEA and androstenedione, or rhGH in the preceding 6 months
- Active cancer requiring therapy and which may limit life expectancy to less than 5 years
- Psychosis, bipolar disorder, or major untreated depression
- Dementia (Mini-Mental Status Exam [MMSE] <24)
- Myocardial infarction (MI) or stroke within 3 months of entry
- Pacemaker
- ALT and AST > 3 x upper limit of normal
- Poorly controlled diabetes as indicated by hemoglobin (Hb)-A1c greater than 9.0% or diabetes requiring insulin therapy
- Blood thinners such as Coumadin, heparin, rivaroxaban (Xarelto), dabigatran (Pradaxa), lovenox (subcutaneous heparin), apixaban (Eliquis) (aspirin, plavix and other anti-platelet agents are allowed)
- Systolic blood pressure (BP) > 170 or diastolic BP > 100 mm Hg
- Current grade 2 or greater pressure ulcers at relevant contact sites
- Pressure sores or open wounds on the areas that restricts their participation
- 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.
- 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.
- Inability or unwillingness to participate in the exercise training or the assessments of muscle performance and physical performance
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
Read the detailed description
Study Description: The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
Objectives:
Primary Objective:
- To determine whether the multimodality intervention is more efficacious in improving peak aerobic capacity, and muscle mass and strength than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry alone.
Secondary Objectives:
- To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving metabolic health, as reflected in fasting glucose, hemoglobin A1C, insulin sensitivity, fat mass and distribution, plasma lipids, and inflammation markers.
- To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving volumetric and areal bone density, bone microarchitecture, and bone strength.
To determine the efficacy of the multimodality intervention in improving self-reported physical function (using SCI-FI AT and wellbeing (mood, anxiety, pain, loneliness and life satisfaction)
- To assess safety by structured monitoring of adverse events, and determining the proportion of participants experiencing injury, erythrocytosis, or other androgen-related or exercise-related adverse events.
Endpoints: Primary Endpoint:
Our primary outcome is peak aerobic capacity because it is an excellent marker of overall health, physical function, and mortality. Aerobic capacity is closely related to metabolic health, insulin sensitivity and cardiovascular outcomes. It can be measured accurately in SCI patients and would be expected to improve with the proposed interventions.
Secondary endpoints. Whole body skeletal muscle and fat mass and intraabdominal fat will be assessed by magnetic resonance imaging (MRI), using the Dixon method for separation of water/ fat signals. Body composition will also be measured by DEXA.
Maximal voluntary strength and muscle fatigability in the upper extremity will be assessed using the 1-repetition maximum in chest press.
Total, trabecular and cortical volumetric bone density; trabecular and cortical microarchitecture, both measured using high resolution peripheral quantitative computed tomography (HR-pQCT) at the ultradistal tibia, proximal tibia, and ultradistal radius.
Estimated bone strength of the ultradistal tibia and radius, assessed using microfinite element analysis of the HR-pQCT data.
Areal bone mineral density of the hip and lumbar spine using dual-energy X-ray absorptiometry (DEXA). (aBMD will be measured because DEXA is a clinically used and accepted measure of bone density, and aBMD is predictive of fracture risk.) Serum bone turnover markers, including markers of bone formation (osteocalcin, bone specific alkaline phosphatase (BSAP), (PINP) and bone resorption (CTX).
Spinal Cord Injury - Functional Index (SCI-FI) will be used to assess self-reported function and mobility. SCI-FI is specific for persons with SCI that assesses functional capacity in basic mobility, ambulation, self-care, and fine motor function, and wheelchair ambulation.
Measures of Metabolism: Fasting glucose, A1C; insulin sensitivity using HOMA-IR; IL-6 and hsCRP as inflammation markers; and plasma lipids, apolipoproteins B, C and A, and lipoprotein particles as markers of atherogenicity - all measured in the Brigham Research Assay Laboratory. Visceral fat will be assessed using Dixon MRI technique.
Wellbeing: We will assess mood, anxiety, pain, and life satisfaction as measures of wellbeing. Mood will be assessed using Patient Health Questionnaire (PHQ-9), a 9-item scale that assesses mood and depressive symptoms. We will assess anxiety using GAD-7. Modified Brief Pain Inventory (BPI), a validated measure of pain in SCI, assesses pain intensity (sensory dimension) and interference with function (reactive dimension). Satisfaction with Life Scale is a 5-item scale that assesses happiness with life. Loneliness will be assessed using the Three-Item Loneliness Scale.
Study Population: This proof-of-concept trial will enroll 88 community dwelling men and women with SCI, 19 to 70 years of age, motor C7-T12 cervical and thoracic, AIS A, B, C, or D, 6 months or later after a SCI.
The trial plans to randomize 84 eligible subjects at a single trial site.
Phase: Phase 2
Description of Sites/Facilities Enrolling Participants: This is a single site study that will take place at the Brigham and Women's Hospital in Boston, MA.
Description of Study Intervention: The Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program includes training at home consisting of FES-LC plus arm ergometry plus testosterone undecanoate. Testosterone injections will be administered by study staff in the research clinic or by a visiting nurse in the participant's home. The control group will receive FES-LC plus arm ergometry plus placebo injections.
Study Duration: Approximately 54 months
Participant Duration: Approximately 33 weeks (14 weeks for screening, baseline studies, and Day 1, 16 weeks of intervention, and up to 3 weeks of end of study assessments)
- Conditions
- Spinal Cord Injuries
- Being tested
- Testosterone Undecanoate, hybrid exercise
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone UndecanoateDrug
administered through injections by study staff
hybrid exerciseBehavioural
hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
| Study group | Role | What they receive |
|---|---|---|
| Multi-modality intervention group | Experimental | Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate Receives: Drug: Testosterone Undecanoate; Behavioral: hybrid exercise |
| Placebo group | Placebo comparator | Hybrid exercise plus placebo medication Receives: Behavioral: hybrid exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone
Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
Measured: Week 16
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Arm Ergometry Exercise Alone
Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
Measured: Week 16
Secondary outcomes (29)
Change From Baseline in VO2 Peak (L/Min) Achieved During FES-LC Exercise Alone
Week 16 change from baseline in peak VO2 aerobic capacity achieved during the functional electrical stimulation -leg cycle (FES-LC) exercise alone
Measured: Week 16
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During FES-LC Exercise Alone
Week 16 change from baseline in peak VO2 aerobic capacity achieved during the functional electrical stimulation -leg cycle (FES-LC) exercise alone
Measured: Week 16
Change From Baseline in VO2 Peak (L/Min) Achieved During Combined FES-LC and AE Exercise
Week 16 change from baseline in the VO2 peak aerobic capacity during the combined functional electrical stimulation- leg cycling (FES-LC) and arm ergometry (AE) exercise
Measured: Week 16
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Combined FES-LC and AE Exercise
Week 16 change from baseline in the VO2 peak aerobic capacity during the combined functional electrical stimulation- leg cycling (FES-LC) and arm ergometry (AE) exercise
Measured: Week 16
Change From Baseline in Work Rate Max During Arm Ergometry Alone
Week 16 change from baseline in Work Rate Max measured in Watts during arm ergometry alone
Measured: Week 16
Change From Baseline in Work Rate Max During FES-LC Exercise Alone
Week 16 change from baseline in Work Rate Max measured in Watts during FES-LC exercise alone
Measured: Week 16
Change From Baseline in Work Rate Max During Combined FES-LC + AE Exercise
Week 16 change from baseline in Work Rate Max measured in Watts during combined FES-LC + AE exercise
Measured: Week 16
Change From Baseline in the One Repetition Maximum (1-RM) Voluntary Strength in the Chest Press Exercise
Week 16 change from baseline in the one repetition maximum (1-RM) voluntary strength in the chest press exercise, measured in force units (Newtons)
Measured: Week 16
Change From Baseline in the Muscle Endurance in the Chest Press Exercise
Week 16 change from baseline muscle endurance in the seated chest press exercise, measured in number of repetitions to failure
Measured: Week 16
Change From Baseline in the Whole Body Lean Mass Measured Using Dual Energy X-ray Absorptiometry (DXA)
Week 16 change from baseline in the whole body lean mass measured using dual energy X-ray absorptiometry (DXA), measured in kg
Measured: Week 16
Change From Baseline in the Upper Extremity Lean Tissue Mass Measured Using DXA
Week 16 change from baseline in the upper extremity lean tissue mass measured using DXA, measured in kg
Measured: Week 16
Change From Baseline in the Lower Extremity Lean Tissue Mass Measured Using DXA
Week 16 change from baseline in the lower extremity lean tissue mass measured using DXA, measured in kg
Measured: Week 16
Change From Baseline in the Trunk Lean Tissue Mass Measured Using DXA
Week 16 change from baseline in the trunk lean tissue mass measured using DXA, measured in kg
Measured: Week 16
Change From Baseline in the Appendicular Lean Tissue Mass Measured Using DXA
Week 16 change from baseline in the appendicular lean tissue mass measured using DXA, measured in kg
Measured: Week 16
Change From Baseline in Fasting Glucose
Week 16 change from baseline in Fasting Glucose
Measured: Week 16
Change From Baseline in Hemoglobin A1C
Week 16 change from baseline in Hemoglobin A1C
Measured: Week 16
Change From Baseline Homeostatic Model Assessment for Insulin Resistance
Week 16 change from baseline in insulin sensitivity will be measured as Homeostatic Model Assessment - Insulin Resistance Index. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) scores measure insulin sensitivity, with lower scores indicating better health. Generally, scores below 1.0 are considered optimal, 1.0 -1.9 indicates normal insulin sensitivity, 2.0 - 2.9 suggests early insulin resistance, and greater or equal than 3.0 indicates significant resistance, typically rising to greater or equal than 5.0 in type 2 diabetes.
Measured: 16 weeks
Change From Baseline in Total Cholesterol
Week 16 change from baseline in total cholesterol, measured in mg/dL
Measured: Week 16
Change From Baseline in Low-density Lipoprotein
Week 16 change from baseline in Low-density lipoprotein, measured as mg/dL
Measured: Week 16
Change From Baseline in Non-HDL Cholesterol
Week 16 change from baseline in non-HDL cholesterol, measured in mg/dL
Measured: Week 16
Change From Baseline in HDL Cholesterol
Week 16 change from baseline in HDL cholesterol, measured in mg/dL
Measured: Week 16
Change From Baseline in Triglycerides
Week 16 change from baseline in triglycerides, measured in mg/dL
Measured: Week 16
Change From Baseline in Inflammatory Markers
Week 16 change from baseline in hsCRP, measured in ng/mL
Measured: Week 16
Change From Baseline in Self-reported Function and Mobility (SCI-FI) (Basic Mobility Standardized Score: 31.97 - 68.48), With a Higher Score Indicating Better Mobility
Week 16 change from baseline self-reported function and mobility measured by the Spinal Cord Injury Function Index (SCI-FI). The Basic Mobility Standardized T-Score comes from the Self-reported Function and Mobility (SCI-FI) Questionnaire. The Basic Mobility Standardized T-Score ranges from 31.97 to 68.48, with a mean of 50 and a standard deviation of 10. A higher Basic Mobility Standardized T-Score indicates better mobility.
Measured: Week 16
Change From Baseline in Depressive Symptoms, Ascertained Using the Patient Health Questionnaire - 9 (PHQ-9) (Score: 0-27), With a Higher Score Indicating More Severe Depression
Week 16 change from baseline in depressive symptoms, ascertained using the Patient Health Questionnaire - (PHQ-9). The score range is 0 to 27. A higher score indicates more severe depression.
Measured: Week 16
Change From Baseline in Pain and Its Impact on Life, Ascertained Using the Brief Pain Inventory (BPI) (Score:0 - 10), With a Higher Score Indicating More Pain
Week 16 change from baseline Brief Pain Inventory (BPI). Score range is 0 to 10. Higher scores indicate worse pain. Severity Score (0-10): Mean of 4 items (worst, least, average, and current pain).
Measured: Week 16
Change From Baseline in Loneliness, Using a 3-item Loneliness Questionnaire (Score: 3-9), With a Higher Score Indicating More Loneliness
Week 16 change from baseline three-Item Loneliness Scale. Score range is 3 to 9, with a score of 3 indicating the least loneliness and 9 the most loneliness.
Measured: Week 16
Change From Baseline in Satisfaction With Life, Ascertained Using the Satisfaction With Life Scale (SWLS) (Score: 5 - 35), With a Higher Score Indicating More Satisfaction With Life
Week 16 change from baseline in satisfaction with life, ascertained using the Satisfaction with Life Scale (SWLS). The score range is from 5 to 35. Higher scores indicate more satisfaction with life.
Measured: Week 16
Change From Baseline in Anxiety Ascertained Using the Generalized Anxiety Disorder - 7 Scale (GAD-7) (Score: 0 - 21), With a Higher Score Indicating Worse Anxiety
Week 16 change from baseline in anxiety ascertained using the Generalized Anxiety Disorder - 7 scale (GAD-7). Score range is 0 to 21. A higher score indicates worse anxiety.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start23 Aug 2019
- Primary completion15 Jan 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, Shalendar Bhasin, MD, Brigham and Women's Hospital
- Investigators
- Shalender Bhasin, MB BS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576001
- Sponsor's protocol ID
- 2018P001431
- Other IDs
- R01HD093724-01
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2018
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valderrabano RJ, Pencina K, Shang YV, Echevarria E, Dixon R, Ghattas C, Wilson L, Reid KF, Storer T, Garrahan M, Tedtsen T, Zafonte R, Bouxsein M, Bhasin S. Bone microarchitectural alterations associated with spinal cord injury: Relation to sex hormones, metabolic factors, and loading. Bone. 2024 Apr;181:117039. doi: 10.1016/j.bone.2024.117039. Epub 2024 Feb 5.
PubMed 38325649Reid KF, Storer TW, Pencina KM, Valderrabano R, Latham NK, Wilson L, Ghattas C, Dixon R, Nunes A, Bajdek N, Huang G, Skeels SE, Lin AP, Merugumala SM, Liao HJ, Bouxsein ML, Zafonte RD, Bhasin S. A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial. BMC Musculoskelet Disord. 2022 May 25;23(1):493. doi: 10.1186/s12891-022-05441-3.
PubMed 35614404
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03576001
- Acronym / sponsor ID
- 2018P001431
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Spaulding Rehabilitation Hospital
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
Detailed description
Study Description: The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
Objectives:
Primary Objective:
- To determine whether the multimodality intervention is more efficacious in improving peak aerobic capacity, and muscle mass and strength than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry alone.
Secondary Objectives:
- To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving metabolic health, as reflected in fasting glucose, hemoglobin A1C, insulin sensitivity, fat mass and distribution, plasma lipids, and inflammation markers.
- To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving volumetric and areal bone density, bone microarchitecture, and bone strength.
To determine the efficacy of the multimodality intervention in improving self-reported physical function (using SCI-FI AT and wellbeing (mood, anxiety, pain, loneliness and life satisfaction)
- To assess safety by structured monitoring of adverse events, and determining the proportion of participants experiencing injury, erythrocytosis, or other androgen-related or exercise-related adverse events.
Endpoints: Primary Endpoint:
Our primary outcome is peak aerobic capacity because it is an excellent marker of overall health, physical function, and mortality. Aerobic capacity is closely related to metabolic health, insulin sensitivity and cardiovascular outcomes. It can be measured accurately in SCI patients and would be expected to improve with the proposed interventions.
Secondary endpoints. Whole body skeletal muscle and fat mass and intraabdominal fat will be assessed by magnetic resonance imaging (MRI), using the Dixon method for separation of water/ fat signals. Body composition will also be measured by DEXA.
Maximal voluntary strength and muscle fatigability in the upper extremity will be assessed using the 1-repetition maximum in chest press.
Total, trabecular and cortical volumetric bone density; trabecular and cortical microarchitecture, both measured using high resolution peripheral quantitative computed tomography (HR-pQCT) at the ultradistal tibia, proximal tibia, and ultradistal radius.
Estimated bone strength of the ultradistal tibia and radius, assessed using microfinite element analysis of the HR-pQCT data.
Areal bone mineral density of the hip and lumbar spine using dual-energy X-ray absorptiometry (DEXA). (aBMD will be measured because DEXA is a clinically used and accepted measure of bone density, and aBMD is predictive of fracture risk.) Serum bone turnover markers, including markers of bone formation (osteocalcin, bone specific alkaline phosphatase (BSAP), (PINP) and bone resorption (CTX).
Spinal Cord Injury - Functional Index (SCI-FI) will be used to assess self-reported function and mobility. SCI-FI is specific for persons with SCI that assesses functional capacity in basic mobility, ambulation, self-care, and fine motor function, and wheelchair ambulation.
Measures of Metabolism: Fasting glucose, A1C; insulin sensitivity using HOMA-IR; IL-6 and hsCRP as inflammation markers; and plasma lipids, apolipoproteins B, C and A, and lipoprotein particles as markers of atherogenicity - all measured in the Brigham Research Assay Laboratory. Visceral fat will be assessed using Dixon MRI technique.
Wellbeing: We will assess mood, anxiety, pain, and life satisfaction as measures of wellbeing. Mood will be assessed using Patient Health Questionnaire (PHQ-9), a 9-item scale that assesses mood and depressive symptoms. We will assess anxiety using GAD-7. Modified Brief Pain Inventory (BPI), a validated measure of pain in SCI, assesses pain intensity (sensory dimension) and interference with function (reactive dimension). Satisfaction with Life Scale is a 5-item scale that assesses happiness with life. Loneliness will be assessed using the Three-Item Loneliness Scale.
Study Population: This proof-of-concept trial will enroll 88 community dwelling men and women with SCI, 19 to 70 years of age, motor C7-T12 cervical and thoracic, AIS A, B, C, or D, 6 months or later after a SCI.
The trial plans to randomize 84 eligible subjects at a single trial site.
Phase: Phase 2
Description of Sites/Facilities Enrolling Participants: This is a single site study that will take place at the Brigham and Women's Hospital in Boston, MA.
Description of Study Intervention: The Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program includes training at home consisting of FES-LC plus arm ergometry plus testosterone undecanoate. Testosterone injections will be administered by study staff in the research clinic or by a visiting nurse in the participant's home. The control group will receive FES-LC plus arm ergometry plus placebo injections.
Study Duration: Approximately 54 months
Participant Duration: Approximately 33 weeks (14 weeks for screening, baseline studies, and Day 1, 16 weeks of intervention, and up to 3 weeks of end of study assessments)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-modality intervention group | Experimental | Drug: Testosterone Undecanoate, Behavioral: hybrid exerciseHybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate |
| Placebo group | Placebo comparator | Behavioral: hybrid exerciseHybrid exercise plus placebo medication |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Medically stable, able to follow directions
- Able to provide informed consent.
- 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.
Key exclusion criteria (25 listed)
- 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.
- Current fractures in the upper and lower extremity
- In accordance with the Endocrine Society and ISSAM Guidelines25,52, we will exclude individuals with a contraindication for androgen use:
- Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain.
- Body mass index (BMI) > 45 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone Undecanoateadministered through injections by study staff | Drug | Multi-modality intervention group |
| hybrid exercisehybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based | Behavioural | Multi-modality intervention group, Placebo group |
Primary outcome
Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone
Time frame: Week 16
Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Arm Ergometry Exercise Alone
Time frame: Week 16
Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
29 secondary outcomes
Change From Baseline in VO2 Peak (L/Min) Achieved During FES-LC Exercise Alone
Time frame: Week 16
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During FES-LC Exercise Alone
Time frame: Week 16
Change From Baseline in VO2 Peak (L/Min) Achieved During Combined FES-LC and AE Exercise
Time frame: Week 16
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Combined FES-LC and AE Exercise
Time frame: Week 16
Change From Baseline in Work Rate Max During Arm Ergometry Alone
Time frame: Week 16
Change From Baseline in Work Rate Max During FES-LC Exercise Alone
Time frame: Week 16
Change From Baseline in Work Rate Max During Combined FES-LC + AE Exercise
Time frame: Week 16
Change From Baseline in the One Repetition Maximum (1-RM) Voluntary Strength in the Chest Press Exercise
Time frame: Week 16
Change From Baseline in the Muscle Endurance in the Chest Press Exercise
Time frame: Week 16
Change From Baseline in the Whole Body Lean Mass Measured Using Dual Energy X-ray Absorptiometry (DXA)
Time frame: Week 16
Change From Baseline in the Upper Extremity Lean Tissue Mass Measured Using DXA
Time frame: Week 16
Change From Baseline in the Lower Extremity Lean Tissue Mass Measured Using DXA
Time frame: Week 16
Change From Baseline in the Trunk Lean Tissue Mass Measured Using DXA
Time frame: Week 16
Change From Baseline in the Appendicular Lean Tissue Mass Measured Using DXA
Time frame: Week 16
Change From Baseline in Fasting Glucose
Time frame: Week 16
Change From Baseline in Hemoglobin A1C
Time frame: Week 16
Change From Baseline Homeostatic Model Assessment for Insulin Resistance
Time frame: 16 weeks
Change From Baseline in Total Cholesterol
Time frame: Week 16
Change From Baseline in Low-density Lipoprotein
Time frame: Week 16
Change From Baseline in Non-HDL Cholesterol
Time frame: Week 16
Change From Baseline in HDL Cholesterol
Time frame: Week 16
Change From Baseline in Triglycerides
Time frame: Week 16
Change From Baseline in Inflammatory Markers
Time frame: Week 16
Change From Baseline in Self-reported Function and Mobility (SCI-FI) (Basic Mobility Standardized Score: 31.97 - 68.48), With a Higher Score Indicating Better Mobility
Time frame: Week 16
Change From Baseline in Depressive Symptoms, Ascertained Using the Patient Health Questionnaire - 9 (PHQ-9) (Score: 0-27), With a Higher Score Indicating More Severe Depression
Time frame: Week 16
Change From Baseline in Pain and Its Impact on Life, Ascertained Using the Brief Pain Inventory (BPI) (Score:0 - 10), With a Higher Score Indicating More Pain
Time frame: Week 16
Change From Baseline in Loneliness, Using a 3-item Loneliness Questionnaire (Score: 3-9), With a Higher Score Indicating More Loneliness
Time frame: Week 16
Change From Baseline in Satisfaction With Life, Ascertained Using the Satisfaction With Life Scale (SWLS) (Score: 5 - 35), With a Higher Score Indicating More Satisfaction With Life
Time frame: Week 16
Change From Baseline in Anxiety Ascertained Using the Generalized Anxiety Disorder - 7 Scale (GAD-7) (Score: 0 - 21), With a Higher Score Indicating Worse Anxiety
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38325649Valderrabano RJ, Pencina K, Shang YV, Echevarria E, Dixon R, Ghattas C, Wilson L, Reid KF, Storer T, Garrahan M, Tedtsen T, Zafonte R, Bouxsein M, Bhasin S. Bone microarchitectural alterations associated with spinal cord injury: Relation to sex hormones, metabolic factors, and loading. Bone. 2024 Apr;181:117039. doi: 10.1016/j.bone.2024.117039. Epub 2024 Feb 5.
- Derived from this study: PubMed 35614404Reid KF, Storer TW, Pencina KM, Valderrabano R, Latham NK, Wilson L, Ghattas C, Dixon R, Nunes A, Bajdek N, Huang G, Skeels SE, Lin AP, Merugumala SM, Liao HJ, Bouxsein ML, Zafonte RD, Bhasin S. A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial. BMC Musculoskelet Disord. 2022 May 25;23(1):493. doi: 10.1186/s12891-022-05441-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalender Bhasin, MB BS principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone Undecanoate and hybrid exercise in people with Spinal Cord Injuries, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576001, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.