Trial Outcomes & Findings for Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury (NCT NCT01272011)

NCT ID: NCT01272011

Last Updated: 2016-03-29

Results Overview

Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Pre- versus Post-treatment

Results posted on

2016-03-29

Participant Flow

Recruitment occurred from October, 2010 through April, 2014 through the North Florida/South Georgia VA Medical Center's Brain Rehabilitation Research Center.

Different study arms were carried out in different phases. The time individuals were enrolled determined which arm they were involved with. Participants enrolling knew which arm we currently were recruiting for. Individuals enrolled in early arms were invited back to other arms of the study if they chose--however, this was not a requirement.

Participant milestones

Participant milestones
Measure	Phase 1 Arm (Pilot) This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.	Phase 2 Arm (LTF) This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.	Phase 3 Arm (Ventilatory Loading) This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
Overall Study STARTED	3	10	3
Overall Study COMPLETED	3	8	3
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 Arm (Pilot) This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.	Phase 2 Arm (LTF) This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.	Phase 3 Arm (Ventilatory Loading) This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
Overall Study Withdrawal By Subject or Failed Screen	0	2	0

Baseline Characteristics

Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Arm (Pilot) n=3 Participants This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.	Phase 2 Arm (Long Term Facilitation) n=8 Participants This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.	Phase 3 Arm (Ventilatory Loading) n=3 Participants This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Age, Continuous	52 years n=5 Participants	53.13 years n=7 Participants	48.33 years n=5 Participants	51.86 years n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	8 participants n=7 Participants	3 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre- versus Post-treatment

Outcome measures

Outcome measures
Measure	Phase 1 Arm (Pilot) Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc) Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days. Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns.	Phase 2 Arm (LTF) n=8 Participants Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation. Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.	Phase 3 Arm (Ventilatory Loading) Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading. Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Minute Ventilation - Phase 2 Daily Acute Effects - Initial	—	22.0 percentage of baseline Standard Error 5.2	—
Minute Ventilation - Phase 2 Daily Acute Effects - Final	—	18.6 percentage of baseline Standard Error 3.6	—
Minute Ventilation - Phase 2 Cumulative Effects - Initial	—	22.0 percentage of baseline Standard Error 5.2	—
Minute Ventilation - Phase 2 Cumulative Effects - Final	—	22.1 percentage of baseline Standard Error 6.9	—

SECONDARY outcome

Timeframe: Pre- versus Post-treatment

Population: Data were collected from 3 participants. However, clinical observations revealed results of interest from only 1/3 of the participants. Therefore, data from only this 1 individual were analyzed for presentation as a case study. The data from the other 2 participants were not analyzed.

Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment.

Outcome measures

Outcome measures
Measure	Phase 1 Arm (Pilot) Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc) Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days. Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns.	Phase 2 Arm (LTF) Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation. Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.	Phase 3 Arm (Ventilatory Loading) n=1 Participants Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading. Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Ventilatory Loading - Phase 3 P vs R Baseline	—	—	-0.12 unitless Standard Error 0.02
Ventilatory Loading - Phase 3 P vs R Post Day 10 IH	—	—	-0.17 unitless Standard Error 0.02
Ventilatory Loading - Phase 3 AF vs R Baseline	—	—	-0.003 unitless Standard Error 0.001
Ventilatory Loading - Phase 3 AF vs R Post Day 10 IH	—	—	-0.0004 unitless Standard Error 0.002

Adverse Events

Phase 1 Arm (Pilot)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2 Arm (Long Term Facilitation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 3 Arm (Ventilatory Loading)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nicole Tester

Malcom Randall VAMC

Phone: 352-376-1611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place