Trial Outcomes & Findings for Effect of Exercise Training on Physical, Cognitive, and Behavioral Function in People With TBI (NCT NCT02504866)
NCT ID: NCT02504866
Last Updated: 2023-11-18
Results Overview
Trail Making Test (TMT) is a neuropsychological assessment of visual conceptual and visual motor tracking (involves motor speed and attention functions). Trail Making Test Part B (TMT-B) is associated with executive functioning and involves drawing a line connecting alternating numbers and letters in sequence (i.e., 1-A-2-B and so on). The time to complete the test is recorded. The time taken to complete the test was converted into standardized T-scores, representing a mean of 50 and a standard deviation of 10. Higher T-scores mean less cognitive deficits. The change in cognitive function was reported as the change in TMT-B T-scores across the 12 weeks (post minus pre intervention).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Before (pre) and after (post) 12 weeks intervention
Results posted on
2023-11-18
Participant Flow
Of the 20 subjects consented, four subjects withdrew prior to being randomized, five subjects were screen failures. Three of the four subjects from the Waitlist Control arm (CON) were further randomized to either AET or RET
Participant milestones
| Measure |
Aerobic Exercise Intervention (AET)
Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks
|
Rapid-Resistive Exercise Intervention (RET)
Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks
|
Waitlist Control (CON)
Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either Aerobic Exercise Intervention (AET) or Rapid-Resistive Exercise Intervention (RET) after the initial 12 weeks.
|
|---|---|---|---|
|
3-Month Follow up
STARTED
|
4
|
3
|
4
|
|
3-Month Follow up
COMPLETED
|
4
|
3
|
4
|
|
3-Month Follow up
NOT COMPLETED
|
0
|
0
|
0
|
|
6-Month Follow up (CON Group Only)
STARTED
|
1
|
2
|
0
|
|
6-Month Follow up (CON Group Only)
COMPLETED
|
0
|
2
|
0
|
|
6-Month Follow up (CON Group Only)
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Aerobic Exercise Intervention (AET)
Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks
|
Rapid-Resistive Exercise Intervention (RET)
Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks
|
Waitlist Control (CON)
Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either Aerobic Exercise Intervention (AET) or Rapid-Resistive Exercise Intervention (RET) after the initial 12 weeks.
|
|---|---|---|---|
|
6-Month Follow up (CON Group Only)
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Exercise Training on Physical, Cognitive, and Behavioral Function in People With TBI
Baseline characteristics by cohort
| Measure |
Aerobic Exercise Intervention (AET)
n=4 Participants
Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks
|
Rapid-Resistive Exercise Intervention (RET)
n=3 Participants
Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks
|
Waitlist Control (CON)
n=4 Participants
Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either AET or RET after the initial 12 weeks.
|
Total
n=11 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
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Before (pre) and after (post) 12 weeks interventionPopulation: The analyses included only those subjects who completed TMT-B at baseline and 3-month follow-up time points.
Trail Making Test (TMT) is a neuropsychological assessment of visual conceptual and visual motor tracking (involves motor speed and attention functions). Trail Making Test Part B (TMT-B) is associated with executive functioning and involves drawing a line connecting alternating numbers and letters in sequence (i.e., 1-A-2-B and so on). The time to complete the test is recorded. The time taken to complete the test was converted into standardized T-scores, representing a mean of 50 and a standard deviation of 10. Higher T-scores mean less cognitive deficits. The change in cognitive function was reported as the change in TMT-B T-scores across the 12 weeks (post minus pre intervention).
Outcome measures
| Measure |
Aerobic Exercise Intervention (AET)
n=4 Participants
Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks
|
Rapid-Resistive Exercise Intervention (RET)
n=3 Participants
Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks
|
Waitlist Control (CON)
n=4 Participants
Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either AET or RET after the initial 12 weeks.
|
|---|---|---|---|
|
Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)
|
4.5 T-score
Standard Deviation 3.7
|
-6.33 T-score
Standard Deviation 29.02
|
-6.75 T-score
Standard Deviation 17.17
|
Adverse Events
Aerobic Exercise Intervention (AET)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Rapid-Resistive Exercise Intervention (RET)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Waitlist Control (CON)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aerobic Exercise Intervention (AET)
n=5 participants at risk
Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks
|
Rapid-Resistive Exercise Intervention (RET)
n=5 participants at risk
Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks
|
Waitlist Control (CON)
n=4 participants at risk
Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
20.0%
1/5 • 9 months
|
0.00%
0/5 • 9 months
|
0.00%
0/4 • 9 months
|
Other adverse events
| Measure |
Aerobic Exercise Intervention (AET)
n=5 participants at risk
Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks
|
Rapid-Resistive Exercise Intervention (RET)
n=5 participants at risk
Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks
|
Waitlist Control (CON)
n=4 participants at risk
Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/5 • 9 months
|
0.00%
0/5 • 9 months
|
25.0%
1/4 • 9 months
|
|
Endocrine disorders
hypoglycaemia
|
0.00%
0/5 • 9 months
|
20.0%
1/5 • 9 months
|
0.00%
0/4 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
40.0%
2/5 • 9 months
|
0.00%
0/5 • 9 months
|
0.00%
0/4 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 9 months
|
20.0%
1/5 • 9 months
|
0.00%
0/4 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
20.0%
1/5 • 9 months
|
0.00%
0/5 • 9 months
|
0.00%
0/4 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • 9 months
|
20.0%
1/5 • 9 months
|
0.00%
0/4 • 9 months
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 9 months
|
20.0%
1/5 • 9 months
|
0.00%
0/4 • 9 months
|
|
Nervous system disorders
Presyncope
|
20.0%
1/5 • 9 months
|
20.0%
1/5 • 9 months
|
0.00%
0/4 • 9 months
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/5 • 9 months
|
20.0%
1/5 • 9 months
|
0.00%
0/4 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place