Trial Outcomes & Findings for Exercise Study of Function and Pathology for Women With X-linked Adrenoleukodystrophy (NCT NCT01594853)
NCT ID: NCT01594853
Last Updated: 2018-08-29
Results Overview
Here, we will assess whether the degree of a person's white matter integrity (i.e. for tracts of interest as measured from MRI) predicts their ability to benefit from exercise. Our prediction is that those individuals with preserved white matter integrity will show the greatest improvement in hip flexor strength.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 18).
Results posted on
2018-08-29
Participant Flow
Participant milestones
| Measure |
Female Carriers
Female carriers will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
Healthy Controls
Healthy age and gender matched individuals will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Female Carriers
Female carriers will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
Healthy Controls
Healthy age and gender matched individuals will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
noncompliance with exercise
|
0
|
1
|
Baseline Characteristics
Exercise Study of Function and Pathology for Women With X-linked Adrenoleukodystrophy
Baseline characteristics by cohort
| Measure |
Female Carriers
n=14 Participants
Female carriers will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched individuals will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
51.3 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
51.7 years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 18).Population: For the follow up visit, there are fewer participants in the analysis because 5 female carriers and 1 control were unable to return for the third follow up visit due to burden to travel costs.
Here, we will assess whether the degree of a person's white matter integrity (i.e. for tracts of interest as measured from MRI) predicts their ability to benefit from exercise. Our prediction is that those individuals with preserved white matter integrity will show the greatest improvement in hip flexor strength.
Outcome measures
| Measure |
Female Carriers
n=14 Participants
Female carriers will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched individuals will participate in an exercise paradigm.
exercise training: The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
|
|---|---|---|
|
Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training
Change post-training
|
0.94 kg
Standard Deviation 1.14
|
0.98 kg
Standard Deviation 2.01
|
|
Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training
Change at follow up
|
1.32 kg
Standard Deviation 1.28
|
1.37 kg
Standard Deviation 1.68
|
Adverse Events
Female Carriers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
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