- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01219647
Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis (CogEx)
December 5, 2014 updated by: Barbara Giesser, University of California, Los Angeles
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Los Angeles, California, United States, 90095
- UCalifornia at Los Angeles
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Northridge, California, United States, 91330
- CAl State University at Northridge
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
subjects will particiopate in supervised stretching as described in arm description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Paced Auditory Serial Addition Test (PASAT)
Time Frame: 36 weeks
|
test of attention and information processing
|
36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symbol Digit Modalities Test (SDMT)
Time Frame: 36 weeks
|
test of attention and information processing
|
36 weeks
|
VO2 max
Time Frame: 36 weeks
|
measure of fitness via oxygen consumption and use
|
36 weeks
|
Long latency cognitive event related potentials ( LLCERP)
Time Frame: 36 weeks
|
electrophysiologic tests of information processing
|
36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Barbara Giesser, MD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
October 8, 2010
First Submitted That Met QC Criteria
October 12, 2010
First Posted (Estimate)
October 13, 2010
Study Record Updates
Last Update Posted (Estimate)
December 9, 2014
Last Update Submitted That Met QC Criteria
December 5, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neurocognitive Disorders
- Cognition Disorders
- Multiple Sclerosis
- Sclerosis
- Cognitive Dysfunction
Other Study ID Numbers
- RG 4174A5/2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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