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Promoting Physical Activity Behavior in Persons With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew Plow, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01572207
First received: March 28, 2012
Last updated: January 22, 2015
Last verified: January 2015

March 28, 2012
January 22, 2015
July 2011
July 2012   (final data collection date for primary outcome measure)
Changes From Baseline in Physical Activity Behavior [ Time Frame: Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]

Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean.

With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity.

Changes from baseline in physical activity behavior [ Time Frame: Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]
Physical activity behavior will be measured with the Physical Activity and Disability Survey, the Godin Leisure-Time Exercise Questionnaire, and an exercise log.
Complete list of historical versions of study NCT01572207 on ClinicalTrials.gov Archive Site
  • Changes From Baseline in Physical Fitness [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]
    The physical assessment will include measuring the 6-minute walk test. The units reported are in meters for distance traveled by each participant during the six minutes. For this scale, the higher number is the better score as it is a direct measure of distance traveled.
  • Changes From Baseline in Quality of Life [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]
    The Multiple Sclerosis Impact Scale will be administered. The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome). Therefore, the lower the number, the better the outcome.
  • Changes from baseline in physical fitness [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]
    The physical assessment will include measuring body morphology (height and weight), cardiovascular endurance, physical function, endurance strength, flexibility, agility, and manual dexterity.
  • Changes from baseline in quality of life [ Time Frame: Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline). ] [ Designated as safety issue: No ]
    The SF-12 and the Multiple Sclerosis Impact Scale will be administered.
Not Provided
Not Provided
 
Promoting Physical Activity Behavior in Persons With Multiple Sclerosis
Using Targeted Print-material to Promote Physical Activity Behavior in Adults With Multiple Sclerosis

The purpose of this research study is to evaluate whether tailored print material can promote physical activity and exercise, and subsequently improve quality of life and fitness levels among people with multiple sclerosis (MS). Research suggests that routine physical activity is beneficial in people with mild to moderate MS. However, people with MS may face many barriers for engaging in regular physical activity. Prescribing a home exercise program and receiving tailored motivational print material may help people engage in physical activity. Thus, the investigators hope to figure out whether tailored print material can be used as strategy to promote physical activity and improve physical function in people with MS.

The objective of the proposed study is to further our understanding of methods to promote physical activity (PA) in people with multiple sclerosis (MS). The investigators will evaluate the efficacy of a print-based multifaceted intervention that consists of prescribing an exercise program and teaching self-management strategies.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Multiple Sclerosis
  • Behavioral: Immediate exercise
    Subjects in the immediate exercise group will be prescribed a home exercise program during the first meeting and will begin the 12 week training period immediately following the first meeting.
    Other Name: Treatment arm
  • Behavioral: Delayed exercise
    Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.
    Other Name: control arm
  • Experimental: Immediate Exercise
    Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
    Intervention: Behavioral: Immediate exercise
  • Experimental: Delayed exercise
    Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
    Intervention: Behavioral: Delayed exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A physician-confirmed diagnosis of relapsing-remitting MS

Exclusion Criteria:

  • Exercise more than 150 minutes per week
  • Pregnant
  • Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible)
  • Four or more falls in the past 6 months
  • Be able to walk 25 feet with or without a cane
  • Severe cognitive deficits
  • Unable to read at a 6th grade level
  • A condition besides MS that had lead to hospitalization in the past year
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01572207
10-531, 1R03HD060073-01A1
No
Matthew Plow, Case Western Reserve University
Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Matthew Plow, PhD Case Western Reserve University
Case Western Reserve University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP