Autonomy and participation in exercise in persons with Multiple Sclerosis

Study ID
STU 072013-011

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Cynthia Dolezal
214-648-2735
cindy.dolezal@utsouthwestern.edu

Principal Investigator
Samuel Bierner

Summary

This study is a prospective, cross-sectional study designed to enlist persons with MS from a wide variety of socioeconomic statuses. The outcome variable will be the completed exercise diary including type of exercise and minutes per week.

The maximum number of local subjects to be consented on this protocol, including projected screen failures and early withdrawals is 100. The total number of subjects needed to complete the study is 68 with subject participation expected to be 3-4 months.

During the initial visit subjects will be screened for inclusion/exclusion criteria. if the subject meets the criteria the study investigator will ask a standard set of questions covering demographics and illness variables (length of time since diagnosis, disease modifying drugs being used, pain level, bowel and bladder dysfunction, use of assistive devices, etc.).

Validated measures to be completed:
1) The Guy's neurological Disability Scale (GnDS) will be administered. This validated measure for disability in MS has several advantages: it is valid when applied by non-neurologists it can be administered over the phone or via a postal questionnaire.

2) in order to measure the subjects' beliefs about exercise we will administer two standardized questionnaires at the time they begin the study. The first will be the Multidimensional outcome expectations for exercise Scale (MoeeS) 19. This consists of 15 items on a 5-point scale. This questionnaire has been studied and found to be valid in a cross-sectional study of ambulatory patients with MS.

3) additionally, we will use the impact on Participation and autonomy (iPa) questionnaire to determine each patient's level of autonomy and participation in everyday life. This questionnaire consists of 32 items on a 5-point scale that evaluate autonomy in five categories: autonomy indoors, family role, autonomy outdoors, social life and relationships, and work and education.

Physical Measures to be completed:
We will measure physical capacity at the time of entry into the study using two measurements: one will be used to determine upper body strength the other to measure lower extremity walking speed. We will use Jay-Mar grip dynamometry to obtain a standardized measurement of grip strength (alternating hands method) to compare with the group as well as age/gender based normal values established in the literature.

in order to evaluate lower extremity functional strength we will use the 2-minute walk test, which has been validated as a measurement tool for lower extremity function in MS.

each subject will be provided written information about general exercise principles in MS to encourage their exercise participation. Subjects will then be asked to complete a daily exercise diary for 2 weeks following the initial visit. This diary will be returned using a self addressed stamped envelope. We will measure the exercise habits (type of exercise and minutes per week) of the subjects based on their completed exercise diaries.

in order to avoid drop-out of subjects, we will use telephone follow-up interviews to capture information on exercise if the diary is not completed and returned by 3 weeks following the initial visit. at 3 months post visit, we will interview by telephone all subjects to re-assess minutes of exercise done per week and administer the GnDS for a second time.

Participant Eligibility


* Age between 18 and 70;

* Subject has been diagnosed by a physician with multiple sclerosis;