Promoting Physical Activity Behavior in Persons With Multiple Sclerosis

NCT01572207 | Completed Results

• 2 other identifiers: 10-5311R03HD060073-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Exercise; Physical activity; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes From Baseline in Physical Fitness

  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

  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).

Study Arms (2)

Immediate Exercise

EXPERIMENTAL

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

Delayed exercise

EXPERIMENTAL

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

Interventions

Immediate exercise 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.

Also known as: Treatment arm

Immediate Exercise

Delayed exercise BEHAVIORAL

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

Also known as: control arm

Delayed exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A physician-confirmed diagnosis of relapsing-remitting MS

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Results Point of Contact

• Title: Matthew Plow
• Organization: Case Western Reserve University

map208@case.edu

216-368-8969

Study Officials

• Matthew Plow, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Scientist

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 6, 2012
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 5, 2022
• Results First Posted: January 26, 2015

Record last verified: 2021-12

Locations

US (1)