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

Multiple Sclerosis Clinical Trial

— CogEx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219647
• Other study ID #: RG 4174A5/2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 8, 2010
• Last updated: December 5, 2014
• Start date: July 2010
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National MS Society
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• exercise
subjects will participate in one of two forms of exercise
• stretching
subjects will particiopate in supervised stretching as described in arm description.

Locations

Country	Name	City	State
United States	UCalifornia at Los Angeles	Los Angeles	California
United States	CAl State University at Northridge	Northridge	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	California State University, Northridge

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paced Auditory Serial Addition Test (PASAT)	test of attention and information processing	36 weeks	No
Secondary	Symbol Digit Modalities Test (SDMT)	test of attention and information processing	36 weeks	No
Secondary	VO2 max	measure of fitness via oxygen consumption and use	36 weeks	No
Secondary	Long latency cognitive event related potentials ( LLCERP)	electrophysiologic tests of information processing	36 weeks	No