Back to resultsExercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis (CogEx)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
exercise
stretching
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Exercise, Cognition
Eligibility 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
Sites / Locations
- UCalifornia at Los Angeles
- CAl State University at Northridge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aerobic exercise
stretching
Arm Description
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 particiate in supervised stretching at same frauency, duration and intensity of aerobic exericse arm
Outcomes
Primary Outcome Measures
Paced Auditory Serial Addition Test (PASAT)
test of attention and information processing
Secondary Outcome Measures
Symbol Digit Modalities Test (SDMT)
test of attention and information processing
VO2 max
measure of fitness via oxygen consumption and use
Long latency cognitive event related potentials ( LLCERP)
electrophysiologic tests of information processing
Full Information
NCT ID
NCT01219647
First Posted
October 8, 2010
Last Updated
December 5, 2014
Sponsor
University of California, Los Angeles
Collaborators
California State University, Northridge
1. Study Identification
Unique Protocol Identification Number
NCT01219647
Brief Title
Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis
Acronym
CogEx
Official Title
Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
California State University, Northridge
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Exercise, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aerobic exercise
Arm Type
Experimental
Arm Description
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
Arm Title
stretching
Arm Type
Active Comparator
Arm Description
Subjects will particiate in supervised stretching at same frauency, duration and intensity of aerobic exericse arm
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
subjects will participate in one of two forms of exercise
Intervention Type
Behavioral
Intervention Name(s)
stretching
Intervention Description
subjects will particiopate in supervised stretching as described in arm description.
Primary Outcome Measure Information:
Title
Paced Auditory Serial Addition Test (PASAT)
Description
test of attention and information processing
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Symbol Digit Modalities Test (SDMT)
Description
test of attention and information processing
Time Frame
36 weeks
Title
VO2 max
Description
measure of fitness via oxygen consumption and use
Time Frame
36 weeks
Title
Long latency cognitive event related potentials ( LLCERP)
Description
electrophysiologic tests of information processing
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Giesser, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCalifornia at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
CAl State University at Northridge
City
Northridge
State/Province
California
ZIP/Postal Code
91330
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis
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