Dr. Grunseich explained that NIH is currently accepting patients for this trial. The doctor also provided information on the type of candidates they are hoping to recruit, the length of the trial and other pertinent information.
A. 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
- This trial is a ‘single-blind’ study.
- NIH hopes to recruit 50 qualified candidates
- The subjects will be in the study for a total of 16 weeks- 12 weeks of exercise and then a 4 week follow up period. The person would go to NIH at the beginning and then again 12 weeks later.
- NIH will pick up the costs for travel expenses.
- Genetically confirmed SBMA.
- Ambulatory and walk a distance of at least 50 feet with or without a walker.
- Able to stand for 10 minutes without the use of any assistive devices.
- Willing to travel to the NIH at the beginning and end of the study.
- Willing to participate in telephone monitoring.
- AMAT (adult myositis assessment tool test) score of less than 41, but greater than 14.
- Male.
- Willing to participate in all aspects of trial design and follow-up.
- Access to a computer with an internet connection
- Able to do all of the exercises according to the standards of the study examiners at the beginning and end of the study
- Willing to forgo starting an additional exercise plan for the 12 week duration of the study
- Age greater than 18 years
- KDA News: 06/10/11 - Clinical Research Study on Kennedy’s Disease
- KDA Chat Room Transcript: http://www.kennedysdisease.org/provide-support/2011-chat-room-transcripts/472-2011-july-16-nih-clinical-trial-on-exercise
- NIH Notification of Trial: http://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2011-N-0171.html
- NIH Contact: Angela Kokkinis at NIH
- Telephone: 301-451-8146
- Email: akokkinis@cc.nih.gov
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