Multiple Sclerosis
Conditions
Keywords
physical activity
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.
Interventions
A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
BEHAVIORALWellness for MS (WellMS)
A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of moderate to vigorous physical activity - Baseline | Assessment will be conducted before the 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. |
| Minutes of moderate to vigorous physical activity - Post intervention | Assessment will be conducted immediately after the 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| distance walked - baseline | Assessment will be conducted before the intervention | The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping. |
| distance walked - post-intervention | Assessment will be conducted immediately after the intervention | The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping. |
| information processing speed; cognitive function - baseline | Assessment will be conducted before the intervention | The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols. |
| information processing speed; cognitive function - post intervention | Assessment will be conducted immediately after the intervention | The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols. |
| cardiorespiratory fitness; oxygen consumption during exercise - baseline | Assessment will be conducted before the 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. |
| volume of subcortical grey matter brain structures - post intervention | Assessment will be conducted immediately after the intervention | An MRI will be conducted to measure brain structure. |
| resting state functional brain connectivity - baseline | Assessment will be conducted before the intervention | An MRI will be conducted to measure brain function. |
| resting state functional brain connectivity - post intervention | Assessment will be conducted immediately after the intervention | An MRI will be conducted to measure brain function. |
| volume of subcortical grey matter brain structures - baseline | Assessment will be conducted before the intervention | An MRI will be conducted to measure brain structure. |
| cardiorespiratory fitness; oxygen consumption during exercise - post intervention | Assessment will be conducted immediately after the 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. |
Countries
United States
Outcome results
None listed