Promoting Physical Activity Behavior in Persons With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using Targeted Print-material to Promote Physical Activity Behavior in Adults With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Immediate exercise
* Behavioral: Delayed exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Exercise<br>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. | Behavioral: Immediate exercise<br>* 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.<br>* Other names: Treatment arm;|
| Experimental: Delayed exercise<br>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. | Behavioral: Delayed exercise<br>* Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.<br>* Other names: control arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Physical Activity Behavior | 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. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Physical Fitness | 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. | 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). | 
| Changes From Baseline in Quality of Life | 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. | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Exercise, Physical activity, Quality of life