- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472442
Intermittent Hypoxia Paired With High Intensity Training in Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Hornby, PT, PhD
- Phone Number: (312) 329-2353
- Email: tghornby@Iu.edu
Study Contact Backup
- Name: Chris Henderson, PT, PhD
- Phone Number: (312) 329-2353
- Email: henderce@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46254
- Recruiting
- Rehabilitation Hospital of Indiana
-
Contact:
- Thomas Hornby, PT, PhD
- Phone Number: 317-329-2353
- Email: tghornby@Iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- > 6 months post brain injury
- 18-75 years old
- ability to walk without physical assistance
- Self selected walking speed of 0.01-1.0 m/s
Exclusion Criteria:
- <18 years old
- ->75 years old
- self selected walking speed of > 1.0 m/s
- < 3 months from botulinum toxin injection above the knee brace
- Currently receiving physical therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Intensity Training with Intermittent Hypoxia
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.
|
Acute intermittent treatment (AIH) will be initiated using an oxygen generator (Model HYP-123, Hypoxico Inc, New York, NY, and participants will be seated comfortably and fitted with a non-rebreather mask. AIH (using 9% O2) will be provided in 60 s intervals and repeated 15 times with alternating 60 s intervals of normoxia (21% O2). Continuous pulse oximetry (Masimo 7, Irvine CA) will be monitored to ensure oxygen saturation of 82-85%. Signs and symptoms of distress with AIH exposure will be noted throughout, with HR and blood pressure taken every 3-5 minutes and documented. High-intensity training will then be performed (40 min of walking training up to 70-80% maximum heart rate within 1 hr). |
Sham Comparator: High Intensity Training with Sham Hypoxia
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.
|
Sham acute intermittent treatment (sham AIH) will be initiated using an oxygen generator (Model HYP-123, Hypoxico Inc, New York, NY, and participants will be seated comfortably and fitted with a non-rebreather mask. Sham AIH (using 20% O2) will be provided in 60 s intervals and repeated 15 times with alternating 60 s intervals of normoxia (21% O2). Continuous pulse oximetry (Masimo 7, Irvine CA) will be monitored to ensure oxygen saturation of 82-85%. Signs and symptoms of distress with AIH exposure will be noted throughout, with HR and blood pressure taken every 3-5 minutes and documented. High-intensity training will then be performed (40 min of walking training up to 70-80% maximum heart rate within 1 hr). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gait speed
Time Frame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
|
Gait speed is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates.
This measure will be performed by blinded assessors who do not participate in the training.
Gait speed will be measured at self-selected speeds (SSS; instructions to "walk at normal comfortable pace") and fastest-possible speed (FS: "as fast as you safely can") using the Zeno Walkway (Protokinetics, Haverton, PA).
|
Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
|
Change in Endurance
Time Frame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
|
Endurance is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates.
This measure will be performed by blinded assessors who do not participate in the training.
Gait endurance will be tested using the 6MWT (m) with instructions similar to SSS to minimize fall risk.
|
Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic capacity
Time Frame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
|
Peak metabolic capacity will be observed during graded exercise testing on a treadmill wtih peak oxygen consumption
|
Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IU2001598586
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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