Clinical trial NCT04496804: Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
Official title: BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: physical activity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Minutes of moderate to vigorous physical activity - Baseline
timeFrame: Assessment will be conducted before the intervention
measure: Minutes of moderate to vigorous physical activity - Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
Secondary outcomes:
measure: cardiorespiratory fitness; oxygen consumption during exercise - baseline
timeFrame: Assessment will be conducted before the intervention
measure: cardiorespiratory fitness; oxygen consumption during exercise - post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: distance walked - baseline
timeFrame: Assessment will be conducted before the intervention
measure: distance walked - post-intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: information processing speed; cognitive function - baseline
timeFrame: Assessment will be conducted before the intervention
measure: information processing speed; cognitive function - post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: volume of subcortical grey matter brain structures - baseline
timeFrame: Assessment will be conducted before the intervention
measure: volume of subcortical grey matter brain structures - post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: resting state functional brain connectivity - baseline
timeFrame: Assessment will be conducted before the intervention
measure: resting state functional brain connectivity - post intervention
timeFrame: Assessment will be conducted immediately after the intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Robert Motl, PhD
role: PRINCIPAL_INVESTIGATOR
References: