NCT01824550

Brief Summary

The objective of this study is to determine the effect of home-based, aerobic exercise training on subclinical atherosclerosis and mobility disability in persons with Multiple Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both subclinical atherosclerosis and mobility disability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

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

November 13, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

April 1, 2013

Last Update Submit

September 24, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Subclinical atherosclerosis

    This will me measured through carotid intima media thickness, flow mediated dilation of forearm, and aortic pulse wave velocity

    3 months

Secondary Outcomes (1)

  • Mobility disability

    3 months

Other Outcomes (1)

  • Disease state, and fatigue

    3 months

Study Arms (2)

home-based exercise training condition

EXPERIMENTAL

Home based endurance exercise training

Other: home-based exercise training condition

attention control condition

NO INTERVENTION

Attention control condition - home based flexibility training

Interventions

home-based exercise training conditionOTHER

Home based endurance exercise training

home-based exercise training condition

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physically inactive
  • BMI\<40
  • st stage of MS (i.e., defined as EDSS score of 0 - 4.0)
  • independently ambulatory (walking without an assistive device such as a cane or orthotic)
  • relapse free in the past 30 days
  • confirmed diagnosis of MS
  • asymptomatic (i.e., no underlying clinically diagnosed cardiovascular disease)
  • be on a stable disease modifying therapy
  • physician approval for undertaking exercise testing and training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bo Fernhall, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean and Professor

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 4, 2013

Study Start

November 13, 2012

Primary Completion

September 7, 2017

Study Completion

September 7, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

US(1)