NCT00334100

Brief Summary

The purpose of the study is to determine whether treadmill training is safe and beneficial in patients with walking difficulty because of multiple sclerosis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

5.4 years

First QC Date

June 2, 2006

Last Update Submit

October 7, 2014

Conditions

Multiple Sclerosis

Keywords

Exercisemultiple sclerosistreadmill

Outcome Measures

Primary Outcomes (1)

  • Peak VO2 Treadmill, Step activity monitors, Timed 8 meter walk

    Pre study and 12 weeks Post study

Study Arms (1)

Arm 1

OTHER
Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Treadmill exercise

Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic definite multiple sclerosis
  • Visible paraparetic gait deficits
  • EDSS 4 to 6.5
  • Last 12 months of care in VHS
  • Competent to provide consent and carry out study procedures
  • Pass the Functional Mobility Entry Test

You may not qualify if:

  • Performing 20 minutes or more of aerobic exercise 3X per week
  • Alcohol consumption over 2 oz liquor, 8 oz wine, 24 oz beer per day
  • Cardiac history
  • Significant medical history
  • Significant neurological history
  • Relapsing MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, 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

  • Christopher Bever, MD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

April 1, 2006

Primary Completion

September 1, 2011

Study Completion

December 1, 2014

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

US(1)