Trial Outcomes & Findings for Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients (NCT NCT02441179)
NCT ID: NCT02441179
Last Updated: 2016-05-27
Results Overview
The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Change from baseline in gait speed five days after daily IH.
Results posted on
2016-05-27
Participant Flow
67 eligible subjects from 4 hospitals were contacted for screening on site: "Hospital Mutual de seguridad", "Instituto Teletón", "Clínica los Coihues" and "Hospital del Trabajador".Only 38 accepted the invitation. The main reason subjects reported to not participate was a tight working schedule and/or lack of employer's permission.
Out of 38 eligible subjects, three were excluded due to brain trauma history and unknown cognitive deficits.Thus, 35 subjects were enrolled and randomly assigned to the arms.
Participant milestones
| Measure |
Acute Intermittent Hypoxia Arm
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Acute Intermittent Hypoxia Arm
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients
Baseline characteristics by cohort
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 17 • n=5 Participants
|
42 years
STANDARD_DEVIATION 17 • n=7 Participants
|
41 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in gait speed five days after daily IH.Population: Analysis was "per protocol"
The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.
Outcome measures
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Gait Speed With 10-Meter Walk Test
|
-10.24 seconds
Standard Error 3.0
|
-1.79 seconds
Standard Error 1.75
|
SECONDARY outcome
Timeframe: Change from baseline in gait indurance five days after daily IH.Population: The analysis was "per protocol"
The 6-Minute Walk Test measures the distance (in meters) a patient is able to walk over 6 minutes.
Outcome measures
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Gait Endurance With the 6-Minute Walk Test
|
43.06 meters
Standard Error 10.68
|
6.13 meters
Standard Error 3.41
|
SECONDARY outcome
Timeframe: Change from baseline in gait speed five days after daily IH.Population: The analysis was "per protocol"
The timed up and go test measures the time (in seconds) it takes the patient to stand-up from a seated position in a chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down.
Outcome measures
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Gait Speed With the Timed up and go Test
|
-8.71 seconds
Standard Error 3.72
|
-2.44 seconds
Standard Error 2.28
|
SECONDARY outcome
Timeframe: Muscle tone at week 4.Population: Analysis "per protocol"
The Ashworth Scale assess muscle tone. It is a 5-points scale ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension).
Outcome measures
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale
|
24 percentage of subjects
|
31 percentage of subjects
|
SECONDARY outcome
Timeframe: Pain perception at week 4Population: Analysis "per protocol"
The visual analog test assess general pain intensity. It is a 10-score scale ranging from no pain (score 0) to unbearable pain (score 10).
Outcome measures
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Percentage of Subjects With Worsening Pain Perception on the "The Visual Analog Test"
|
11 percentage of subjects
|
25 percentage of subjects
|
SECONDARY outcome
Timeframe: Episodic visual memory at week 4.Population: Analysis "per protocol"
The ROCF is a neuropsychological instrument used for assessment of episodic visual memory. Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1. Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation
Outcome measures
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test
|
0.19 Z scores
Interval -0.84 to 0.49
|
0.16 Z scores
Interval -0.3 to 0.6
|
SECONDARY outcome
Timeframe: Episodic verbal memory at week 4.Population: Analysis "per protocol"
The TAVEC is the Spanish version of the California Verbal Learning Test and is used for the assessment of episodic verbal memory. Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1. Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation
Outcome measures
| Measure |
Intermittent Hypoxia Arm
n=17 Participants
IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.
|
Normoxia Arm
n=16 Participants
Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.
|
|---|---|---|
|
Learning and Memory With the Complutense Verbal Learning Test (TAVEC)
|
0 Z scores
Interval -0.5 to 1.0
|
0 Z scores
Interval -1.0 to 0.75
|
Adverse Events
Intermittent Hypoxia Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normoxia Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place