Intermittent Hypoxia Paired with High Intensity Training in Brain Injury

NCT04472442 | Completed DMC

• 1 other identifier: IU2001598586
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The central hypotheses are that HIT combined with AIH results in: 1) greater locomotor gains as compared to HIT alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (2)

• Change in gait speed

  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

  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 Outcomes (1)

• Metabolic capacity

  Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks

Study Arms (2)

High Intensity Training with Intermittent Hypoxia

EXPERIMENTAL

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.

Procedure: Intermittent hypoxia

High Intensity Training with Sham Hypoxia

SHAM COMPARATOR

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.

Procedure: Sham hypoxia

Interventions

Intermittent hypoxia PROCEDURE

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).

High Intensity Training with Intermittent Hypoxia

Sham hypoxia PROCEDURE

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).

High Intensity Training with Sham Hypoxia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 6 months post brain injury
• years old
• ability to walk without physical assistance
• Self selected walking speed of 0.01-1.0 m/s

You may not qualify if:

• \<18 years old
• \>85 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

Sponsors & Collaborators

• Indiana University: lead
• Rehabilitation Hospital of Indiana: collaborator

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

Related Publications (1)

• Hornby TG, Plawecki A, Lotter JK, Shoger LH, Voigtmann CJ, Inks E, Henderson CE. Acute Intermittent Hypoxia With High-Intensity Gait Training in Chronic Stroke: A Phase II Randomized Crossover Trial. Stroke. 2024 Jul;55(7):1748-1757. doi: 10.1161/STROKEAHA.124.047261. Epub 2024 Jun 11.

  PMID: 38860389 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Thomas Hornby, PT,PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of both participant with actual vs sham treatment and blinding of primary outcome assessments
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physcial Medicine & Rehabilitation

Model Details: 2-arm, randomized, crossover trial

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 15, 2020
• Study Start: August 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)