Exercise Study of Function and Pathology for Women With X-linked Adrenoleukodystrophy
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ClinicalTrials.gov Identifier: NCT01594853 |
Recruitment Status :
Completed
First Posted : May 9, 2012
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
X-linked Adrenoleukodystrophy |
Intervention |
Behavioral: exercise training |
Enrollment | 31 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Female Carriers | Healthy Controls |
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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 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. |
Period Title: Overall Study | ||
Started | 16 | 15 |
Completed | 14 | 12 |
Not Completed | 2 | 3 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 1 |
Lost to Follow-up | 1 | 1 |
noncompliance with exercise | 0 | 1 |
Arm/Group Title | Female Carriers | Healthy Controls | Total | |
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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 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 of all reporting groups | |
Overall Number of Baseline Participants | 14 | 12 | 26 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 14 participants | 12 participants | 26 participants | |
52.1 (8.4) | 51.3 (12.5) | 51.7 (10.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 14 participants | 12 participants | 26 participants | |
Female |
14 100.0%
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12 100.0%
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26 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 14 participants | 12 participants | 26 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 7.1%
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3 25.0%
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4 15.4%
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White |
13 92.9%
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9 75.0%
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22 84.6%
|
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 14 participants | 12 participants | 26 participants |
14 100.0%
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12 100.0%
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26 100.0%
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Name/Title: | Kathleen Zackowski |
Organization: | Kennedy Krieger Institute |
Phone: | 443-923-2716 |
EMail: | zackowski@kennedykrieger.org |
Responsible Party: | Kathleen Zackowski, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
ClinicalTrials.gov Identifier: | NCT01594853 |
Other Study ID Numbers: |
NA_00045673 |
First Submitted: | May 7, 2012 |
First Posted: | May 9, 2012 |
Results First Submitted: | December 14, 2017 |
Results First Posted: | August 29, 2018 |
Last Update Posted: | August 29, 2018 |