Promoting Physical Activity Behavior in Persons With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew Plow, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01572207
First received: March 28, 2012
Last updated: January 22, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Behavioral: Immediate exercise
Behavioral: Delayed exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Using Targeted Print-material to Promote Physical Activity Behavior in Adults With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Changes From Baseline in Physical Activity Behavior [ Time Frame: 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). ] [ Designated as safety issue: No ]

    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:
  • Changes From Baseline in Physical Fitness [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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.

  • Changes From Baseline in Quality of Life [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Other Name: Treatment arm
Experimental: 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.
Behavioral: Delayed exercise
Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.
Other Name: control arm

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572207

Locations
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Matthew Plow, PhD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Matthew Plow, Project Scientist, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01572207     History of Changes
Other Study ID Numbers: 10-531, 1R03HD060073-01A1
Study First Received: March 28, 2012
Results First Received: August 7, 2013
Last Updated: January 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Multiple Sclerosis
Exercise
Physical activity
Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 25, 2015