Clinical trial NCT01572207: Promoting Physical Activity Behavior in Persons With Multiple Sclerosis
Official title: Using Targeted Print-material to Promote Physical Activity Behavior in Adults With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Exercise
Physical activity
Quality of life
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes From Baseline in Physical Activity Behavior
timeFrame: 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 outcomes:
measure: Changes From Baseline in Physical Fitness
timeFrame: 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).
measure: Changes From Baseline in Quality of Life
timeFrame: 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).
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Matthew Plow, PhD
role: PRINCIPAL_INVESTIGATOR
References: