N/A N=31 Treatment

Exercise Study of Function and Pathology for Women With X-linked Adrenoleukodystrophy

X-linked Adrenoleukodystrophy

Bottom Line

View on ClinicalTrials.gov: NCT01594853 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training — 0.94; 0.98; 1.32; 1.37 kg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: exercise training (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training	0.94; 0.98; 1.32; 1.37	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01594853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.