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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Condition or disease | Intervention/treatment | Phase |
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X-linked Adrenoleukodystrophy | Behavioral: exercise training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Exercise Study of Function and Pathology for Women With X-ALD |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: exercise
Female carriers as well as healthy age and gender matched individuals will participate in an exercise paradigm.
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Behavioral: 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.
Other Names:
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- Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training [ Time Frame: Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 18). ]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.

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Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- confirmed diagnosis, X-ALD heterozygote carrier
- no medical contraindication to participating in a strength training program
- able to follow complex directions as determined by a score of ≤1 on a subset of questions taken from the NIH Stroke scale (Brott et al. 1989)
- hip flexion strength: 6.6-15.8kg
- hip extension strength: up to 18.3 kg
- normal passive range of motion at hips/knees/ankles
- able to walk ≥50m
Exclusion Criteria:
- Evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease
- congestive heart failure
- cancer
- orthopedic conditions
- severe pain that precludes study participation
- seizures
- pregnancy
- other medical condition that precludes participation in an exercise program, e.g., unstable angina, uncontrolled diabetes, uncontrolled hypertension
Healthy controls have the same age and exclusion criteria as women with AMN except that they will not be carriers for X-ALD. They must have normal neurological function.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594853
United States, Maryland | |
Motion Analysis Lab | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Kathleen M Zackowski, Ph.D. | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
Documents provided by Kathleen Zackowski, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Responsible Party: | Kathleen Zackowski, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
ClinicalTrials.gov Identifier: | NCT01594853 |
Other Study ID Numbers: |
NA_00045673 |
First Posted: | May 9, 2012 Key Record Dates |
Results First Posted: | August 29, 2018 |
Last Update Posted: | August 29, 2018 |
Last Verified: | December 2017 |
exercise women training rehabilitation leukodystrophy |
Adrenoleukodystrophy Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Hereditary Central Nervous System Demyelinating Diseases Leukoencephalopathies Demyelinating Diseases Mental Retardation, X-Linked Intellectual Disability |
Neurobehavioral Manifestations Neurologic Manifestations Genetic Diseases, X-Linked Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolism, Inborn Errors Peroxisomal Disorders Metabolic Diseases Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases |