Intermittent Hypoxia Paired with High Intensity Training in Brain Injury

Indiana University

Status: Completed

Conditions: Brain Injuries

Treatments: Procedure: Intermittent hypoxia; Procedure: Sham hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT04472442

IU2001598586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

High Intensity Training with Intermittent Hypoxia

Experimental group

Description:

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.

Treatment:

Procedure: Intermittent hypoxia

High Intensity Training with Sham Hypoxia

Sham Comparator group

Description:

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:

Procedure: Sham hypoxia