The National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of Health (NIH), is conducting a study to assess the safety and effectiveness of exercise in men with spinal-bulbar muscular atrophy (SBMA), also known as Kennedy disease.
The utility of exercise in this disease is uncertain.
A clinical trial is a test, in humans, of an experimental treatment. Although it's possible that benefit may be derived from participating in a clinical trial, it's also possible that no benefit, or even harm, may occur. MDA has no ability to influence who is chosen to participate in a clinical trial. To learn more, see Understanding Clinical Trials and Being a Co-Adventurer, which is about neuromuscular disease clinical trials. To see a continuously updated database of clinical trials, go to www.clinicaltrials.gov.
Those enrolled in the study will be randomly assigned to either a strength or a stretching exercise program.
The study requires two visits to the NIH in Bethesda, Md., 12 weeks of monitoring at home, and a four-week phone and email follow-up period. There are no associated costs to participants.
Those in the trial will be informed of the results and given an opportunity to learn any exercises that are found to be beneficial.
To participate in the SBMA exercise trial
Prospective participants must:
- have genetically confirmed SBMA;
- be willing and able to participate in a 12-week exercise regimen;
- be able to walk short distances;
- be able to participate in a 16-week study with two visits to the NIH in Bethesda, Md.; and
- meet other study criteria.
For details, contact Angela Kokkinis in Bethesda at (301) 451-8146 or firstname.lastname@example.org or Christopher Grunseich in Bethesda at (301) 435-9288 or email@example.com.
See also Effect of Functional Exercise in Patients With Spinal-Bulbar Muscular Atrophy; or enter NCT01369901 in the search box at ClinicalTrials.gov.