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    "path": "/trials/NCT04458324",
    "result": {"pageContext":{"pagePath":"/trials/NCT04458324","trial":{"nct_id":"NCT04458324","brief_title":"Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury","official_title":"Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury","about_trial":"This trial is recruiting individuals with spinal cord injuries to assess modifications to a fitness program called Functional Electrical Stimulation Row Training (FESRT). The program involves using a rowing machine with volitional arm movements and skin-surface electrical stimulation of the weakened or paralyzed leg muscles. The modifications include an external breathing device (non-invasive ventilation; NIV) used during exercise and a drug called Buspar, taken orally twice daily for six months. Participants will complete 6 months of FESRT and will be randomly assigned to one of 4 study groups: 1) NIV + Buspar; 2) NIV + placebo; 3) sham NIV + Buspar; or 4) sham NIV + placebo drug. Training sessions will be conducted 2-3 times per week for 6 months. Final outcome assessments, including aerobic exercise capacity and ventilation during exercise, will be performed after 6 months.","age_from":18,"age_to":50,"ais_a":true,"ais_b":true,"ais_c":true,"ais_d":false,"ais_e":false,"time_since_injury_from":3,"time_since_injury_from_unit":"months","time_since_injury_to":36,"time_since_injury_to_unit":"months","healthy_volunteers":false,"inclusion_criteria":["be a wheelchair user.","NOT have epilepsy, heart disease, diabetes, or cancer"],"study_type":"interventional","allocation":"Randomized","brief_description":"Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. However, despite the potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via hybrid FES exercise, the inability to increase ventilation beyond limits set by high level SCI restricts aerobic capacity.\n\nThis research study will investigate two potential methods of improving ventilation in those with high-level SCI through a double-blind randomized trial. One method is non-invasive ventilation (NIV), which is an external breathing support machine. The second method is the use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats and some human case reports.\n\nIn this study, participants will engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate cardiopulmonary health and fitness.","detailed_description":"The participant will train with a rowing machine using FESRT 2-3times/week for 6 months while receiving 1) NIV + Buspar, or 2) NIV + placebo, or 3) sham NIV + Buspar, or 4) sham NIV + placebo drug.\nFinal outcome testing will be performed after 6 months.","final_testing_performed":null,"version_id":7,"emsci_trial":false,"curation_status":"curated","overall_recruitment_status":"active","primary_intervention":{"id":2,"name":"Drug","parent_id":null,"icon_name":"pill"},"primary_benefit":{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},"sex":"All","injury_level_from":"C1","injury_level_to":"T3","start_date":"2020-12-22","organization":"Spaulding Rehabilitation Hospital","benefits":[{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"}],"injuries":[{"id":3,"name":"Traumatic","parent_id":1,"pivot":{"trial_id":2819,"injury_id":3}}],"interventions":[{"id":2,"name":"Drug","parent_id":null,"icon_name":"pill"},{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},{"id":6,"name":"Psychosocial/other","parent_id":null,"icon_name":"alternative-or-complimentary"}],"outcome_measures":[],"recovery_mechanisms":[],"published_at":"2021-11-05T18:49:22.000000Z","modified_at":"2021-11-05T18:49:22.000000Z"},"layout":"trial"}},
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