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Behavioural Intervention
Oxygen + Strength Training for Spinal Cord Injury
N/A
Waitlist Available
Led By Gordon Mitchell, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 1, day 6, day 8, day 15
Awards & highlights
Study Summary
This trial will test if a combination of short bouts of low oxygen air and respiratory strength training improves breathing function more than either approach alone in people with chronic spinal cord injuries.
Who is the study for?
Adults with chronic spinal cord injury (SCI) for at least a year, who have some remaining sensory or motor function below the injury level, or are medically stable. Not eligible if they have other neurological conditions, uncontrolled medical issues like heart disease, severe pain, recent seizures, pregnancy, or recurrent autonomic dysreflexia.Check my eligibility
What is being tested?
The study is testing whether combining acute intermittent hypoxia (AIH), which involves breathing low oxygen air in short bursts to promote nerve repair, with respiratory strength training improves breathing more than either method alone in adults with SCI using a double blind cross-over design.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from low oxygen levels during AIH and fatigue from respiratory strength training. The trial's design suggests close monitoring of participants for any adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 1, day 6, day 8, day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 1, day 6, day 8, day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in maximal expiratory pressure
Change in maximal inspiratory pressure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Adults with incomplete SCIExperimental Treatment4 Interventions
Adults with chronic, incomplete SCI who have >20% impairment in respiratory function, who will complete a battery of clinical assessments and 4 randomly ordered intervention and testing blocks (Daily AIH Block, Sham dAIH Block, Respiratory Strength Training Block and AIH + Strength Training Block).
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,350 Previous Clinical Trials
719,907 Total Patients Enrolled
United States Department of DefenseFED
869 Previous Clinical Trials
327,659 Total Patients Enrolled
Brooks RehabilitationOTHER
13 Previous Clinical Trials
1,700 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a spinal cord injury for at least 1 year at or below the chest level.It seems like the criterion might be incomplete. Could you please provide more information or clarify the context?You have been diagnosed with another neurological condition like multiple sclerosis, Parkinson's disease, stroke, or brain injury.You have unstable or uncontrolled heart, lung, or bone conditions.You have very severe nerve pain.You have severe and frequent episodes of autonomic dysreflexia.You have had a spinal cord injury for at least a year, and it affects your ability to feel or move below a certain level.You have had a severe spinal cord injury for at least a year, and you have no feeling or movement below a certain level in your spine.You have a spinal cord injury that is not getting worse over time.You have more than 20% lower breathing strength than what is considered normal.You have had a seizure within the past year.You have had a complete spinal cord injury at or below the middle of your neck or upper back for at least one year.You have some feeling or movement below the injury in your spinal cord, or your injury is classified as B, C, or D according to specific guidelines.
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