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

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04496804
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Study Start: 2020-11-02
• Status Verified: 2021-09
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
resting state functional brain connectivity - post intervention	Assessment will be conducted immediately after the intervention	An MRI will be conducted to measure brain function.
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.
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.
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.
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.
resting state functional brain connectivity - baseline	Assessment will be conducted before the intervention	An MRI will be conducted to measure brain function.
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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States