NCT00513448

Brief Summary

The purpose of this study was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2005

Shorter than P25 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

April 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
Last Updated

August 8, 2007

Status Verified

August 1, 2007

First QC Date

August 7, 2007

Last Update Submit

August 7, 2007

Conditions

Multiple Sclerosis

Keywords

Chronic Disabling ConditionComparative EvaluationPhysical ActivityPhysical TherapyRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Modified Fatigue Impact Scale SF-36 Mental Health Inventory

    16 weeks

Secondary Outcomes (1)

  • Physical assessments

    16-weeks

Interventions

Group wellness interventionOTHER
Individualized physical rehabilitationOTHER

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A physician-confirmed diagnosis of MS
  • Between the ages of 18 to 75 years
  • Ability to ambulate 25 meters with or without the use of an adaptive aide

You may not qualify if:

  • Pregnant
  • Cardiovascular disease
  • Had fallen more than twice in the past month
  • Significant cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Matthew A Plow, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

April 1, 2005

Study Completion

November 1, 2005

Last Updated

August 8, 2007

Record last verified: 2007-08

Locations

US(1)