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Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis (CogEx)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
California State University, Northridge
Information provided by (Responsible Party):
Barbara Giesser, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01219647
First received: October 8, 2010
Last updated: November 4, 2013
Last verified: November 2013

October 8, 2010
November 4, 2013
July 2010
July 2014   (final data collection date for primary outcome measure)
Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
test of attention and information processing
Same as current
Complete list of historical versions of study NCT01219647 on ClinicalTrials.gov Archive Site
  • Symbol Digit Modalities Test (SDMT) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    test of attention and information processing
  • VO2 max [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    measure of fitness via oxygen consumption and use
  • Long latency cognitive event related potentials ( LLCERP) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    electrophysiologic tests of information processing
Same as current
Not Provided
Not Provided
 
Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis
Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis

Many persons with Multiple Sclerosis ( MS) have problems with memory and thinking.Exercise has been shown to improve memory and thinking in persons with diseases such as Alzheimer's. This study will investigate whether a program of aerobic exercise can improve memory and thinking in persons with MS

Persons with Multiple Sclerosis(MS)will be screened for eligibility and randomized to a protocol with two intervention arms. One group will have aerobic training on a recumbent cross trainer three times a week for 20-30 minutes/session. The other group will participate in stretching exercises at the same frequency and intensity.Total training time will be six months.Outcome measures will include tests of memory and thinking, and fitness measures.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Behavioral: exercise
    subjects will participate in one of two forms of exercise
  • Behavioral: stretching
    subjects will particiopate in supervised stretching as described in arm description.
  • Experimental: aerobic exercise
    Subjects will train on a recumbent cross trainer 20-30 minutes/session for three times/week for six months under supervision of a fitness specialist
    Intervention: Behavioral: exercise
  • Active Comparator: stretching
    Subjects will particiate in supervised stretching at same frauency, duration and intensity of aerobic exericse arm
    Intervention: Behavioral: stretching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical Diagnosis of MS Complaints of cognitive problems Able to ride a recumbent cross trainer

Exclusion Criteria:

  • Cardiopulmonary or structural disease that would limit ability to participate in exercise training On treatment with chemotherapy or natalizumab Screening score of >50 on PASAT
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01219647
RG 4174A5/2
No
Barbara Giesser, University of California, Los Angeles
University of California, Los Angeles
California State University, Northridge
Principal Investigator: Barbara Giesser, MD University of California, Los Angeles
University of California, Los Angeles
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP