NCT01219647

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 2010

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

4.1 years

First QC Date

October 8, 2010

Last Update Submit

December 5, 2014

Conditions

Keywords

Multiple SclerosisExerciseCognition

Outcome Measures

Primary Outcomes (1)

  • Paced Auditory Serial Addition Test (PASAT)

    test of attention and information processing

    36 weeks

Secondary Outcomes (3)

  • Symbol Digit Modalities Test (SDMT)

    36 weeks

  • VO2 max

    36 weeks

  • Long latency cognitive event related potentials ( LLCERP)

    36 weeks

Study Arms (2)

aerobic exercise

EXPERIMENTAL

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

stretching

ACTIVE COMPARATOR

Subjects will particiate in supervised stretching at same frauency, duration and intensity of aerobic exericse arm

Behavioral: stretching

Interventions

exerciseBEHAVIORAL

subjects will participate in one of two forms of exercise

aerobic exercise
stretchingBEHAVIORAL

subjects will particiopate in supervised stretching as described in arm description.

stretching

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCalifornia at Los Angeles

Los Angeles, California, 90095, United States

Location

CAl State University at Northridge

Northridge, California, 91330, United States

Location

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Barbara Giesser, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clincial Profesor of Neurology

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 13, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations