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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
Sponsor:
Collaborator:
European Leukodystrophy Association
Information provided by (Responsible Party):
Kathleen Zackowski, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 14 participants 12 participants 26 participants
Female
14
 100.0%
12
 100.0%
26
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.1%
3
  25.0%
4
  15.4%
White
13
  92.9%
9
  75.0%
22
  84.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 12 participants 26 participants
14
 100.0%
12
 100.0%
26
 100.0%
1.Primary Outcome
Title Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training
Hide Description 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.
Time Frame Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 18).
Hide Outcome Measure Data
Hide Analysis Population Description
For the follow up visit, there are fewer participants in the analysis because 5 female carriers and 1 control were unable to return for the third follow up visit due to burden to travel costs.
Arm/Group Title Female Carriers Healthy Controls
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: kg
Change post-training Number Analyzed 14 participants 12 participants
0.94  (1.14) 0.98  (2.01)
Change at follow up Number Analyzed 11 participants 9 participants
1.32  (1.28) 1.37  (1.68)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Female Carriers Healthy Controls
Hide Arm/Group Description

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.

All-Cause Mortality
Female Carriers Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Female Carriers Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Female Carriers Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathleen Zackowski
Organization: Kennedy Krieger Institute
Phone: 443-923-2716
EMail: zackowski@kennedykrieger.org
Layout table for additonal information
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