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

Multiple Sclerosis Clinical Trial

— BIPAMS-Brain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496804
• Other study ID #: 300005111
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: November 3, 2021

Study information

• Verified date: September 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Behavioral Intervention for Physical Activity in MS (BIPAMS)
A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
• Wellness 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	volume of subcortical grey matter brain structures - baseline	An MRI will be conducted to measure brain structure.	Assessment will be conducted before the intervention
Secondary	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
Secondary	resting state functional brain connectivity - baseline	An MRI will be conducted to measure brain function.	Assessment will be conducted before the intervention
Secondary	resting state functional brain connectivity - post intervention	An MRI will be conducted to measure brain function.	Assessment will be conducted immediately after the intervention