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Behavioural Intervention

Oxygen + Strength Training for Spinal Cord Injury

N/A
Recruiting
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 weeks
Treatment ~ Varies
Follow Up ~baseline, day 1, day 6, day 8, day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1, day 6, day 8, day 15 for reporting.

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).

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,625 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,546 Total Patients Enrolled
Brooks RehabilitationOTHER
13 Previous Clinical Trials
1,700 Total Patients Enrolled

Media Library

AIH + Strength Training Block (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03833674 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment include geriatric participants?

"Requirements to be eligible for participation in this study specify that all patients must be between the ages of 18 and 70. Conversely, there are 37 separate studies specifically targeting below-age-18 participants, while 310 trials focus on those over 65."

Answered by AI

Is there a possibility for me to participate in this research experiment?

"This clinical trial is seeking 53 individuals between ages 18 and 70 with a spinal cord injury that meets the following standards: complete SCI (as indicated by absence of motor/sensory function below the level of injury or A classification), non-progressive etiology, >20% impairment in maximal inspiratory/expiratory pressure relative to established normative values, chronic incomplete SCI for ≥1 year at C-1 to T-12 levels, and incomplete SCI based on residual sensory/motor ability below the level of injury or B through D classifications according to American Spinal Injury Association Impairment Classification."

Answered by AI

How many participants are included in the scope of this medical experiment?

"Yes, clinicaltrials.gov reflects that this medical trial is actively seeking volunteers to enroll. The project launched on August 15th 2020 and has been updated as recently as August 5th 2022; currently, it's recruiting for 53 participants at a single site."

Answered by AI

Are there still opportunities to participate in this investigation?

"According to the records on clinicaltrials.gov, this medical experiment is currently seeking volunteers for participation. This trial was announced on August 15th 2020 and has been amended as recently as August 5th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Brooks Rehabilitation Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Want to get stronger and better balance.
PatientReceived 2+ prior treatments
~11 spots leftby Apr 2025