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Promoting Physical Activity for Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group wellness intervention
Individualized physical rehabilitation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis focused on measuring Chronic Disabling Condition, Comparative Evaluation, Physical Activity, Physical Therapy, Rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

Modified Fatigue Impact Scale SF-36 Mental Health Inventory

Secondary Outcome Measures

Physical assessments

Full Information

First Posted
August 7, 2007
Last Updated
August 7, 2007
Sponsor
University of Minnesota
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00513448
Brief Title
Promoting Physical Activity for Persons With Multiple Sclerosis
Official Title
Comparing Individualized Rehabilitation to a Group Wellness Intervention for Persons With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Minnesota
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Evidence from this study shows that both interventions were effective in improving health and physical activity in persons with multiple sclerosis. The results also show that participants may benefit more physically from individualized physical rehabilitation and more mentally from group wellness interventions. Interventions that combine individualized therapeutic exercise with group health education might be most effective for persons with multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Chronic Disabling Condition, Comparative Evaluation, Physical Activity, Physical Therapy, Rehabilitation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Group wellness intervention
Intervention Type
Other
Intervention Name(s)
Individualized physical rehabilitation
Primary Outcome Measure Information:
Title
Modified Fatigue Impact Scale SF-36 Mental Health Inventory
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Physical assessments
Time Frame
16-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnant Cardiovascular disease Had fallen more than twice in the past month Significant cognitive deficits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew A Plow, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Promoting Physical Activity for Persons With Multiple Sclerosis

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