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

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ClinicalTrials.gov Identifier: NCT01219647
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : December 9, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: exercise Behavioral: stretching Phase 1 Phase 2

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis
Study Start Date : July 2010
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Behavioral: exercise
subjects will participate in one of two forms of exercise
Active Comparator: stretching
Subjects will particiate in supervised stretching at same frauency, duration and intensity of aerobic exericse arm
Behavioral: stretching
subjects will particiopate in supervised stretching as described in arm description.


Outcome Measures

Primary Outcome Measures :
  1. Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 36 weeks ]
    test of attention and information processing


Secondary Outcome Measures :
  1. Symbol Digit Modalities Test (SDMT) [ Time Frame: 36 weeks ]
    test of attention and information processing

  2. VO2 max [ Time Frame: 36 weeks ]
    measure of fitness via oxygen consumption and use

  3. Long latency cognitive event related potentials ( LLCERP) [ Time Frame: 36 weeks ]
    electrophysiologic tests of information processing


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01219647


Locations
United States, California
UCalifornia at Los Angeles
Los Angeles, California, United States, 90095
CAl State University at Northridge
Northridge, California, United States, 91330
Sponsors and Collaborators
University of California, Los Angeles
California State University, Northridge
Investigators
Principal Investigator: Barbara Giesser, MD University of California, Los Angeles
More Information

Responsible Party: Barbara Giesser, Clincial Profesor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01219647     History of Changes
Other Study ID Numbers: RG 4174A5/2
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Barbara Giesser, University of California, Los Angeles:
Multiple Sclerosis
Exercise
Cognition

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Cognitive Dysfunction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders