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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD093724-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Spaulding Rehabilitation Hospital | OTHER |
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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.
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 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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-modality intervention group | Experimental | Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate |
|
| Placebo group | Placebo Comparator | Hybrid exercise plus placebo medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Undecanoate | Drug | administered through injections by study staff |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 16 |
| Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During FES-LC Exercise Alone |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Shalender Bhasin, MB BS | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38325649 | Derived | 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. | |
| 35614404 | Derived | Reid 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi-modality Intervention Group | Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate |
| FG001 | Placebo Group | Hybrid exercise plus placebo medication |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multi-modality Intervention Group | Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | L/min | Week 16 |
|
16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multi-modality Intervention Group | Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate Testosterone Undecanoate: administered through injections by study staff hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to flu dx and pneumonia | Infections and infestations | Physiologic System | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Physiologic System | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shalender Bhasin | Brigham and Women's Hosptial | 617-732-5661 | sbhasin@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2024 | Mar 23, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2025 | Mar 23, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
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| hybrid exercise | Behavioral | hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based |
|
Week 16 change from baseline in peak VO2 aerobic capacity achieved during the functional electrical stimulation -leg cycle (FES-LC) exercise alone |
| 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | Week 16 |
| Change From Baseline in Fasting Glucose | Week 16 change from baseline in Fasting Glucose | Week 16 |
| Change From Baseline in Hemoglobin A1C | Week 16 change from baseline in Hemoglobin A1C | 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. | 16 weeks |
| Change From Baseline in Total Cholesterol | Week 16 change from baseline in total cholesterol, measured in mg/dL | Week 16 |
| Change From Baseline in Low-density Lipoprotein | Week 16 change from baseline in Low-density lipoprotein, measured as mg/dL | Week 16 |
| Change From Baseline in Non-HDL Cholesterol | Week 16 change from baseline in non-HDL cholesterol, measured in mg/dL | Week 16 |
| Change From Baseline in HDL Cholesterol | Week 16 change from baseline in HDL cholesterol, measured in mg/dL | Week 16 |
| Change From Baseline in Triglycerides | Week 16 change from baseline in triglycerides, measured in mg/dL | Week 16 |
| Change From Baseline in Inflammatory Markers | Week 16 change from baseline in hsCRP, measured in ng/mL | 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. | 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. | 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). | 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. | 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. | 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. | Week 16 |
Hybrid exercise plus placebo medication
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| VO2 Peak (L/min) During CPXT Arm Ergometry Exercise | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | L/min |
|
| VO2 Peak (mL/kg/min) During CPXT Arm Ergometry Exercise | Some values werenot obtained during specific visits due to the Covid-19 shutdown or machine malfunction. | Mean | Standard Deviation | mL/kg/min |
|
| VO2 Peak (L/min) Achieved During FES-LC Exercise Alone | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | L/min |
|
| VO2 Peak (mL/kg/min) Achieved During FES-LC Exercise Alone | Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction. | Mean | Standard Deviation | mL/kg/min |
|
| VO2 Peak (L/min) Achieved During Combined FES-LC and AE Exercise | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | L/min |
|
| VO2 Peak (mL/kg/min) Achieved During Combined FES-LC and AE Exercise | Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction. | Mean | Standard Deviation | mL/kg/min |
|
| Work Rate Max During Arm Ergometry Alone | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | Watts |
|
| Work Rate Max During FES-LC Exercise Alone | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | Watts |
|
| Work Rate Max During Combined FES-LC + AE Exercise | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | Watts |
|
| One Repetition Maximum (1-RM) Voluntary Strength in the Chest Press Exercise | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | N |
|
| Muscle Endurance in the Chest Press Exercise | Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction. | Mean | Standard Deviation | Repetitions to failure |
|
| Whole Body Lean Mass Measured Using Dual Energy X-ray Absorptiometry (DXA) | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | kg |
|
| Upper Extremity Lean Tissue Mass Measured Using DXA | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | kg |
|
| Lower Extremity Lean Tissue Mass Measured Using DXA | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | kg |
|
| Trunk Lean Tissue Mass Measured Using DXA | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | kg |
|
| Appendicular Lean Tissue Mass Measured Using DXA | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | kg |
|
| Fasting Glucose | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1C | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | Percentage of hemoglobin |
|
| Homeostatic Model Assessment for Insulin Resistance | 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. | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | HOMA-IR Score |
|
| Total Cholesterol | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | mg/dL |
|
| Low-density Lipoprotein | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | mg/dL |
|
| Non-HDL Cholesterol | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | mg/dL |
|
| HDL Cholesterol | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | mg/dL |
|
| hsCRP | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | ng/mL |
|
| Self-reported Function and Mobility (SCI-FI) (Basic Mobility Standardized Score) | 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. | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | T-score |
|
| Depressive Symptoms, Ascertained Using the Patient Health Questionnaire - 9 (PHQ-9) (Score: 0-27) | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | Score |
|
| Brief Pain Inventory (BPI) (Score:0 - 10) | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | Score |
|
| Loneliness Questionnaire (Score: 3-9) | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | Score |
|
| Satisfaction With Life Scale (SWLS) (Score: 5 - 35) | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | Score |
|
| Generalized Anxiety Disorder - 7 Scale (GAD-7) (Score: 0 - 21) | Some values were not obtained during specific visits due to the Covid-19 shut down. | Mean | Standard Deviation | Score |
|
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | mL/kg/min | Week 16 |
|
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | L/min | Week 16 |
|
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | mL/kg/min | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | L/min | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | mL/kg/min | Week 16 |
|
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Watts | Week 16 |
|
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Watts | Week 16 |
|
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Watts | Week 16 |
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| Secondary | 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) | Posted | Mean | 95% Confidence Interval | N | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Repetitions | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | kg | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | kg | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | kg | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | kg | Week 16 |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | kg | Week 16 |
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| Secondary | Change From Baseline in Fasting Glucose | Week 16 change from baseline in Fasting Glucose | Posted | Mean | 95% Confidence Interval | mg/dL | Week 16 |
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| Secondary | Change From Baseline in Hemoglobin A1C | Week 16 change from baseline in Hemoglobin A1C | Posted | Mean | 95% Confidence Interval | percentage of hemoglobin | Week 16 |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | HOMA-IR Score | 16 weeks |
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| Secondary | Change From Baseline in Total Cholesterol | Week 16 change from baseline in total cholesterol, measured in mg/dL | Posted | Mean | 95% Confidence Interval | mg/dL | Week 16 |
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| Secondary | Change From Baseline in Low-density Lipoprotein | Week 16 change from baseline in Low-density lipoprotein, measured as mg/dL | Posted | Mean | 95% Confidence Interval | mg/dL | Week 16 |
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| Secondary | Change From Baseline in Non-HDL Cholesterol | Week 16 change from baseline in non-HDL cholesterol, measured in mg/dL | Posted | Mean | 95% Confidence Interval | mg/dL | Week 16 |
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| Secondary | Change From Baseline in HDL Cholesterol | Week 16 change from baseline in HDL cholesterol, measured in mg/dL | Posted | Mean | 95% Confidence Interval | mg/dL | Week 16 |
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| Secondary | Change From Baseline in Triglycerides | Week 16 change from baseline in triglycerides, measured in mg/dL | Posted | Mean | 95% Confidence Interval | mg/dL | Week 16 |
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| Secondary | Change From Baseline in Inflammatory Markers | Week 16 change from baseline in hsCRP, measured in ng/mL | Posted | Mean | 95% Confidence Interval | ng/mL | Week 16 |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | T-Score | Week 16 |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Score | Week 16 |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | Score | Week 16 |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Score | Week 16 |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Score | Week 16 |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Score | Week 16 |
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| 0 |
| 36 |
| 3 |
| 36 |
| 27 |
| 36 |
| EG001 | Placebo Group | Hybrid exercise plus placebo medication hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based | 0 | 44 | 6 | 44 | 36 | 44 |
| Hospitalization of stomach pain | Gastrointestinal disorders | Physiologic System | Non-systematic Assessment |
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| UTI Complication and Hospitalization | Infections and infestations | Physiologic System | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Physiologic System | Non-systematic Assessment |
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| Hospitalization for back pain | Musculoskeletal and connective tissue disorders | Physiologic System | Non-systematic Assessment |
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| Hospitalization for a planned baclofen pump insertion/revision surgery | Surgical and medical procedures | Physiologic System | Non-systematic Assessment |
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| Chronic nonunited left subcapital femoral fracture | Injury, poisoning and procedural complications | Physiologic System | Non-systematic Assessment |
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| RIJ thrombophlebitis | Vascular disorders | Physiologic System | Non-systematic Assessment |
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| Deep face neck infection | Infections and infestations | Physiologic System | Non-systematic Assessment |
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| Hospitalization for an elective penile implant | Surgical and medical procedures | Physiologic System | Non-systematic Assessment |
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| Hospitalization for a planned laparoscopic assisted sigmoid colostomy surgery and an IUD removal | Surgical and medical procedures | Physiologic System | Non-systematic Assessment |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Physiologic System | Non-systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Physiologic System | Non-systematic Assessment |
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| Hepatic/Biliary | Hepatobiliary disorders | Physiologic System | Non-systematic Assessment |
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| Genital/Urinary | Renal and urinary disorders | Physiologic System | Non-systematic Assessment |
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| Endocrine/ Metabolic | Endocrine disorders | Physiologic System | Non-systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Physiologic System | Non-systematic Assessment |
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| Hematologic/Lymphatic | Blood and lymphatic system disorders | Physiologic System | Non-systematic Assessment |
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| Neurologic | Nervous system disorders | Physiologic System | Non-systematic Assessment |
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| Dermatologic | Skin and subcutaneous tissue disorders | Physiologic System | Non-systematic Assessment |
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| Infectious Disease | Infections and infestations | Physiologic System | Non-systematic Assessment |
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| Other | General disorders | Physiologic System | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| Unknown or Not Reported |
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