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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01594853
Other study ID # NA_00045673
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date October 2014

Study information

Verified date December 2017
Source Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to see how X-linked adrenoleukodystrophy (X-ALD) is associated with strength and sensation using MRI, in women with X-ALD. The investigators will also see whether exercise can improve these symptoms for women with X-ALD.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Motion Analysis Lab Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. European Leukodystrophy Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training 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. Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 18).
See also
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Completed NCT04687007 - SMART-ALD - A New Lifestyle Intervention to Improve Quality of Life in Women With X-linked Adrenoleukodystrophy (X-ALD) N/A
Completed NCT01165060 - The Effect of Bezafibrate on the Level of Very Long Chain Fatty Acids (VLCFA) in X-linked Adrenoleukodystrophy (X-ALD) N/A
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Withdrawn NCT01787578 - Safety and Pharmacodynamic Study of Sobetirome in X-Linked Adrenoleukodystrophy (X-ALD) Phase 1
No longer available NCT02233257 - Expanded Access for Lorenzo's Oil (GTO/GTE) in Adrenoleukodystrophy N/A