Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the United States. This disease results in the progressive loss of walking mobility and substantial worsening of cognition, symptoms, and quality of life over time. There is evidence that physical activity is beneficially associated with aerobic fitness and brain structure and function in persons with MS. Nevertheless, this population is strikingly sedentary and physically inactive. This highlights a vital opportunity to improve aerobic fitness and brain health by developing behavioral interventions that increase physical activity. To that end, this project is a Phase-II randomized control trial for examining the efficacy of a behavioral intervention that is based on social-cognitive theory and delivered through the Internet for increasing physical activity and, secondarily, improving aerobic fitness and brain structure and function in persons with MS.

Official Title
-----------------
BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS)
* Behavioral: Wellness for MS (WellMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of multiple sclerosis relapse free in the last 30 days 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 6 months ambulate without assistance low risk for contraindications for MRI Exclusion Criteria: moderate or high risk for undertaking strenuous or maximal exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention for Physical Activity in MS (BIPAMS)<br>The current behavioral intervention consists of two primary components; an Internet website and one-on-one video chats with a behavioral coach. The Internet website involves content delivered through interactive video courses. The interactive video courses are based on elements of social cognitive theory. Each courses consists of an introduction, the primary content, and a take home message. The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic. A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention, discussion of website material, supportive accountability, and reporting of adverse events/injuries. The chats are conducted face-to-face through Skype. The chats occur 7 times during the first 2 months, 4 times during the second 2 months, and twice during the final 2 months of the intervention. | Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS)<br>* A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.<br>|
| Sham Comparator: Wellness for MS (WellMS)<br>Provides an Internet website and one-on-one video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity. The materials are transformations of brochures provided by the National MS Society, 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 not involve tracking steps and a pedometer with not be provided. | Behavioral: Wellness for MS (WellMS)<br>* A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minutes of moderate to vigorous physical activity - Baseline | Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves. | Assessment will be conducted before the intervention | 
| Minutes of moderate to vigorous physical activity - Post intervention | Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves. | Assessment will be conducted immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiorespiratory fitness; oxygen consumption during exercise - baseline | A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill. | Assessment will be conducted before the intervention | 
| cardiorespiratory fitness; oxygen consumption during exercise - post intervention | A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill. | Assessment will be conducted immediately after the intervention | 
| distance walked - baseline | The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping. | Assessment will be conducted before the intervention | 
| distance walked - post-intervention | The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping. | Assessment will be conducted immediately after the intervention | 
| information processing speed; cognitive function - baseline | The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols. | Assessment will be conducted before the intervention | 
| information processing speed; cognitive function - post intervention | The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols. | Assessment will be conducted immediately after the intervention | 
| volume of subcortical grey matter brain structures - baseline | An MRI will be conducted to measure brain structure. | Assessment will be conducted before the intervention | 
| volume of subcortical grey matter brain structures - post intervention | An MRI will be conducted to measure brain structure. | Assessment will be conducted immediately after the intervention | 
| resting state functional brain connectivity - baseline | An MRI will be conducted to measure brain function. | Assessment will be conducted before the intervention | 
| resting state functional brain connectivity - post intervention | An MRI will be conducted to measure brain function. | Assessment will be conducted immediately after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity