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

NCT01594853 | Completed Results

• 1 other identifier: NA_00045673
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

X-linked Adrenoleukodystrophy

Keywords

exercise; women; training; rehabilitation; leukodystrophy

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

exercise

EXPERIMENTAL

Female carriers as well as healthy age and gender matched individuals will participate in an exercise paradigm.

Behavioral: exercise training

Interventions

exercise training BEHAVIORAL

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.

Also known as: strengthening, Curves

exercise

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• European Leukodystrophy Association: collaborator

Study Sites (1)

Motion Analysis Lab

Baltimore, Maryland, 21205, United States

Location

Related Links

• See Clinical Research Projects listing.

MeSH Terms

Conditions

Adrenoleukodystrophy; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

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; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Metabolism, Inborn Errors; Peroxisomal Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Results Point of Contact

• Title: Kathleen Zackowski
• Organization: Kennedy Krieger Institute

zackowski@kennedykrieger.org

443-923-2716

Study Officials

• Kathleen M Zackowski, Ph.D.

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2017-12

Locations

US (1)