Intermittent Hypoxia Paired With High Intensity Training in Brain Injury

Brain Injuries Clinical Trial

Official title:

Intermittent Hypoxia Paired With High Intensity Training in Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472442
• Other study ID #: IU2001598586
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Hypoxia
• Wounds and Injuries

Intervention

Procedure:
• Intermittent hypoxia
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
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).

Locations

Country	Name	City	State
United States	Rehabilitation Hospital of Indiana	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Rehabilitation Hospital of Indiana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Metabolic capacity	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