Brain Injuries
Conditions
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.
Interventions
PROCEDUREIntermittent 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).
PROCEDURESham 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).
Sponsors
Rehabilitation Hospital of Indiana
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding of both participant with actual vs sham treatment and blinding of primary outcome assessments
Intervention model description
2-arm, randomized, crossover trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed