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Promoting Physical Activity Behavior in Persons With Multiple Sclerosis

Not Applicable
Completed
Conditions
Multiple Sclerosis
Interventions
Behavioral: Delayed exercise
Behavioral: Immediate exercise
Registration Number
NCT01572207
Lead Sponsor
Case Western Reserve University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Delayed exerciseDelayed exerciseSubjects 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.
Immediate ExerciseImmediate exerciseSubjects 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.
Primary Outcome Measures
NameTimeMethod
Changes From Baseline in Physical Activity BehaviorEach 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).

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.

Secondary Outcome Measures
NameTimeMethod
Changes From Baseline in Quality of LifeEach 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).

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 FitnessEach 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).

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.

Trial Locations

Locations (1)

The Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
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