Promoting Physical Activity Behavior in Persons With Multiple Sclerosis

NCT ID: NCT01572207

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-07-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Immediate exercise

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Delayed exercise

Intervention Type: BEHAVIORAL

Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.

Interventions

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.

Intervention Type: BEHAVIORAL

Delayed exercise

Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.

Intervention Type: BEHAVIORAL

Other Intervention Names

Treatment arm; control arm

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Matthew Plow

Project Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Plow, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

1R03HD060073-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-531

Identifier Type: -

Identifier Source: org_study_id