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

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
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
NCT ID
NCT00513448
First Posted
August 7, 2007
Last Updated
August 7, 2007
Sponsor
University of Minnesota
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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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