Friday, June 10, 2011

Clinical Research Study on Kennedy’s Disease

For several months now we knew a clinical study was coming.  This week NIH posted the following information on their website.

I feel this is an important study since I am an advocate of the benefits of exercise.  If you are interested in participating in this study, the contact information is near the bottom of this page. 

NIH Clinical Research Studies

  Active Accrual, Protocols Recruiting New Patients

Effect of Functional Exercise in Patients with Spinal and Bulbar Muscular Atrophy
Number: 11-N-0171
 
A.  Summary: Background: Spinal and bulbar muscular atrophy (SBMA) is an inherited disorder that affects men. People with SBMA often have weakness throughout the body, including the muscles they use for swallowing, breathing, and speaking. We do not know if exercise helps or harms people with SBMA.

B.  Objective:
-To see if a 12-week program of either strength exercise or stretching exercises will improve strength, function, or quality of life in people with SBMA

C.  Eligibility:
-Participants will be men 18 years of age or older who have genetic confirmation of SBMA.
-They must be able to walk at least 50 feet with or without an assistive device such as a cane or a walker and stand for 10 minutes without using an assistive device.
-They must have access to a computer with an Internet connection.

D.  Design:
-At the first visit to NIH (2 days), participants will have a medical history taken and undergo a physical exam. They will also have blood tests and an EKG, and complete questionnaires about mood, health, and exercise. Tests of muscle strength, balance, and endurance will also be done.
-Participants who qualify for the study will receive instruction about either strengthening or stretching exercises. They will do these exercises at home one to three times a week for 12 weeks.
-They will wear a small activity monitor while they exercise and record their exercise in a diary.
-At the end of 12 weeks, participants will return to the NIH for 2 days. They will undergo the same tests as they had on the first visit.
-Participants will receive follow-up phone calls and e-mails during the study and for 4 weeks after the last visit.

E.  Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
 
F.  Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male
 
G.  Eligibility Criteria:
INCLUSION CRITERIA:
1. Genetically confirmed SBMA.
2. Ambulatory and walk a distance of at least 50 feet with or without a walker.
3. Able to stand for 10 minutes without the use of any assistive devices.
4. Willing to travel to the NIH at the beginning and end of the study.
5. Willing to participate in telephone monitoring.
6. AMAT score of less than 41, but greater than 14.
7. Male.
8. Willing to participate in all aspects of trial design and follow-up.
9. Access to a computer with an internet connection
10. Able to do all of the exercises according to the standards of the study examiners at the beginning and end of the study
11. Willing to forgo starting an additional exercise plan for the 12 week duration of the study
12. Age greater than 18 years
          EXCLUSION CRITERIA:
1. Medical condition which would preclude exercise such as COPD, congestive heart failure, and cardiac arrhythmias.
2. Presence of an additional comorbid condition such as stroke, myopathy, or radiculopathy which also results in weakness.
3. Beginning a separate exercise program involving at least two weekly sessions of 20 minutes of exercise each within two months of the start of the trial.

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793
Electronic Mail:prpl@mail.cc.nih.gov
Link to the article:  http://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2011-N-0171.html

1 comment:

  1. What would be interesting, after the first round of testing is over, would be to repeat after a few months on Dutestride.

    ReplyDelete

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