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Completed

NCT Number: NCT04472442

Intermittent Hypoxia Paired with High Intensity Training in Brain Injury

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Rehabilitation Hospital of Indiana

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2020
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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