Clinical Trial of Exercise in Patients With Spinal Muscular Atrophy (SMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01166022|
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : August 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Spinal Muscular Atrophy Neuromuscular Disease||Other: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized, Controlled Clinical Trial of Exercise in Patients With Spinal Muscular Atrophy (SMA)|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
U.S. FDA Resources
Muscle strengthening program using weights and resistance bands in combination with a home based cycle ergometry program. The home-based exercise program will be performed up to 5 times weekly.
Muscle strengthening program using hand weights and resistance bands in combination with a home based cycle ergometry. This home-based exercise program will be performed up to 5 times weekly. Each session will consist of up to 30 minutes of cycling and 30 minutes of strengthening.
No Intervention: Typical Activity
Subjects in this group will be asked to maintain their typical daily activity. Those assigned to this arm will be given the opportunity to join the intervention arm seven months after their screening visit.
- Distance walked in the Six Minute Walk Test (6MWT). [ Time Frame: Up to 19 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166022
|United States, New York|
|Columbia University SMA Clinical Research Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Darryl C De Vivo, MD||Columbia University|