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Purpose

This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of MS - Relapse free in the past 30 days - Internet and email access - Willingness to complete the questionnaires, wear the accelerometer, and undergo randomization - Being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months - Ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair) - Age between 18 and 64

Exclusion Criteria

  • Moderate or high risk for undertaking strenuous or maximal exercise per participants response to the PAR-Q. Those who report no more than one YES or affirmative on the 7 item PAR-Q will be considered at low risk and included for participation. All others will be considered at moderate or high risk and excluded from participation.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Participant)
Masking Description
The investigators will advertise the study as comparing two approaches delivered through the Internet for managing consequences of MS and improving health indicators. On randomization, the investigators will again reaffirm this position with the participant. The participant will not be informed about which condition is the control or the intervention.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BIPAMS 		The behavioral intervention consists of two primary components, a dedicated Internet website and one-on-one video chats with a behavioral coach via Skype. The behavioral intervention focuses on the skills, techniques, resources, and strategies for becoming and staying physically active with MS, but it does not provide a prescription for exercise or physical activity itself.
  • Behavioral: BIPAMS
    The primary content of the website is delivered through interactive video courses. The interactive video courses are released seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention. Another key part of the website is the Tracker feature. This feature allows for tracking of daily step counts (via Yamax SW-200 pedometer) as well as setting goals and monitoring progress over the program. The one-on-one video chats are conducted face to face through skype and are semi-scripted. The chats consist of an ongoing review of goal-setting and progress toward goal attainment through Tracker as well as discussion of strategies and facilitators of behavioral change based on SCT and current website content. The chats occur seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.
Active Comparator
WELLMS 		The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.
  • Behavioral: WELLMS
    The control condition focuses on self-managing MS through means other than physical activity. The materials are transformations of brochures provided by the NMSS, including Gait or Walking Problems: The Basic Facts; MS and Your Emotions; Pain: The Basic Facts; Solving Cognitive Problems; Taming Stress in MS; Food for Thought: MS and Nutrition; and Vitamins, Minerals, and Herbs: An Introduction. The delivery of the Internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition, and will have a comparable time commitment. The control condition will account for attention and social contact as well as other possible biases such as initial reactivity and time spent on the website and video chats. The participants in the control condition will not be offered the behavioral intervention for increasing physical activity after completion of the study procedures.

More Details

Status
Active, not recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.