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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS); Behavioral: Wellness for MS (WellMS)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Intervention for Physical Activity in MS (BIPAMS); 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); A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
Sham Comparator: Wellness for MS (WellMS); 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); A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Robert Motl, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: physical activity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 300005111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No