Exercise as a Strategy to Treat Cognitive Dysfunction in... | NCT01219647

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

NCT01219647

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Dec 9, 2014Estimated

Enrollment

35Actual

Phase

Phase 1Phase 2

Conditions

Multiple Sclerosis

Interventions

exercise
stretching

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Oct 8, 2010

First Submission Date that Met QC Criteria

Oct 12, 2010

First Posted Date

Oct 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2014

Last Update Posted Date

Dec 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Barbara Giesser, Clincial Profesor of Neurology, University of California, Los AngelesPrincipal Investigator

Lead Sponsor

University of California, Los AngelesOTHER

Collaborators

Name	Class
California State University, Northridge	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
exercise	Behavioral	subjects will participate in one of two forms of exercise	aerobic exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Paced Auditory Serial Addition Test (PASAT)	test of attention and information processing	36 weeks

Secondary Outcomes

Measure	Description	Time Frame
Symbol Digit Modalities Test (SDMT)	test of attention and information processing	36 weeks
VO2 max	measure of fitness via oxygen consumption and use

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Giesser, MD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCalifornia at Los Angeles		Los Angeles	California	90095	United States
CAl State University at Northridge

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D009043	Motor Activity

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided