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Behavioural Intervention

Intermittent Hypoxia + High-Intensity Training for Traumatic Brain Injury

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to walk without physical assistance

18-75 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline 1, post 1 after 6 weeks, baseline 2, post 2 after 6 weeks

Awards & highlights

Study Summary

This trial looks at the effects of HIT combined with AIH on locomotor gains, gait quality, motor coordination, and measures of community participation and integration.

Who is the study for?

This trial is for adults aged 18-75 who had a brain injury at least 6 months ago and can walk unassisted, albeit slowly (0.01-1.0 m/s). It's not suitable for those over 75, walking faster than 1.0 m/s, recently treated with certain muscle relaxants, or currently in physical therapy.Check my eligibility

What is being tested?

The study tests if high-intensity training (HIT) combined with artificial intermittent hypoxia (AIH) improves walking and coordination more than HIT alone in people recovering from brain injuries. It also looks at the impact on community participation.See study design

What are the potential side effects?

Potential side effects may include discomfort due to low oxygen levels during AIH sessions and increased fatigue or muscle soreness from the high-intensity training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own without help.

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I am between 18 and 75 years old.

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I can walk, but my pace is slow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline 1, post 1 after 6 weeks, baseline 2, post 2 after 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline 1, post 1 after 6 weeks, baseline 2, post 2 after 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 1, post 1 after 6 weeks, baseline 2, post 2 after 6 weeks 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 Endurance

Gait

Secondary outcome measures

Metabolic capacity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High Intensity Training with Intermittent HypoxiaExperimental Treatment1 Intervention

The primary goal will be provide acute intermittent hypoxia (9% PO2; 1 min on 1 min off) prior to stepping training while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). Sessions will be divided into ~10 minute increments (~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing.

Group II: High Intensity Training with Sham HypoxiaPlacebo Group1 Intervention

The primary goal will be provide sham intermittent hypoxia (20% PO2) prior to performing continuous stepping while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). Sessions will be divided into ~10 minute increments (~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intermittent hypoxia

2019

N/A

~100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rehabilitation Hospital of IndianaOTHER

12 Previous Clinical Trials

5,529 Total Patients Enrolled

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,256 Total Patients Enrolled

Media Library

Intermittent hypoxia (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04472442 — N/A

Traumatic Brain Injury Research Study Groups: High Intensity Training with Intermittent Hypoxia, High Intensity Training with Sham Hypoxia

Traumatic Brain Injury Clinical Trial 2023: Intermittent hypoxia Highlights & Side Effects. Trial Name: NCT04472442 — N/A

Intermittent hypoxia (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04472442 — N/A

Frequently Asked Questions

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

To whom is this clinical trial open for enrollment?

"This clinical trial is recruiting 20 patients, aged between 18 and 75, who have suffered a traumatic brain injury within the past 6 months. Additionally, these individuals must be able to independently ambulate in a speed range of 0.01-1.0 m/s without requiring physical assistance."

Answered by AI

Is this research study open for enrollment?

"Affirmative, clinicaltrials.gov has stated that this research project is seeking volunteers. It was published on August 1st 2020 and the most recent update to its details was made on April 30th 2021. The study requires 20 patients to be recruited from one location."

Answered by AI

Are elderly individuals excluded from participating in the experiment?

"Prospective patients between the ages of 18 and 75 are qualified to join this trial. Those under 18 or over 65 have additional 190 and 796 trials, respectively, that they can consider joining."

Answered by AI

What is the cap on participants accepted into this clinical trial?

"Affirmative, clinicaltrials.gov conveys that this research is presently enlisting participants. It was initially advertised on August 1st 2020 and most recently modified on April 30th 2021. The trial requires the recruitment of 20 test subjects at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intermittent Hypoxia Paired With High Intensity Training in Brain Injury

George Hornby 2020. "Intermittent Hypoxia Paired With High Intensity Training in Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04472442.

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