Intermittent Hypoxia Paired with High Intensity Training in Brain Injury

Not Applicable

Completed

• Conditions: Brain Injuries
• Interventions: Procedure: Sham hypoxia; Procedure: Intermittent hypoxia

• Registration Number: NCT04472442
• Lead Sponsor: Indiana University

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.

Detailed Description

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. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of safety, feasibility, and preliminary efficacy of HIT+AIH. In this phase I-II trial, patients \>6 months post-BI with mobility deficits will be allocated to 5 weeks (15 sessions) of HIT+AIH or HIT alone. Blinded assessments will be performed prior to and following training paradigms to address 3 specific aims.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-15
• Study Start: 2020-08-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• > 6 months post brain injury
• 18-85 years old
• ability to walk without physical assistance
• Self selected walking speed of 0.01-1.0 m/s

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Exclusion Criteria

• <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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Intensity Training with Sham Hypoxia	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.
High Intensity Training with Intermittent Hypoxia	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.

Primary Outcome Measures

Name	Time	Method
Change in gait speed	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).
Change in Endurance	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.

Secondary Outcome Measures

Name	Time	Method
Metabolic capacity	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

Trial Locations

Locations (1)

Rehabilitation Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States