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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention for Physical Activity in MS (BIPAMS)
Wellness for MS (WellMS)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring physical activity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Behavioral Intervention for Physical Activity in MS (BIPAMS)

Wellness for MS (WellMS)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
distance walked - baseline
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
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
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
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
An MRI will be conducted to measure brain structure.
volume of subcortical grey matter brain structures - post intervention
An MRI will be conducted to measure brain structure.
resting state functional brain connectivity - baseline
An MRI will be conducted to measure brain function.
resting state functional brain connectivity - post intervention
An MRI will be conducted to measure brain function.

Full Information

First Posted
July 29, 2020
Last Updated
February 2, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04496804
Brief Title
Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
Acronym
BIPAMS-Brain
Official Title
BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention for Physical Activity in MS (BIPAMS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Wellness for MS (WellMS)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention for Physical Activity in MS (BIPAMS)
Intervention Description
A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
Intervention Type
Behavioral
Intervention Name(s)
Wellness for MS (WellMS)
Intervention Description
A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.
Primary Outcome Measure Information:
Title
Minutes of moderate to vigorous physical activity - Baseline
Description
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.
Time Frame
Assessment will be conducted before the intervention
Title
Minutes of moderate to vigorous physical activity - Post intervention
Description
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.
Time Frame
Assessment will be conducted immediately after the intervention
Secondary Outcome Measure Information:
Title
cardiorespiratory fitness; oxygen consumption during exercise - baseline
Description
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.
Time Frame
Assessment will be conducted before the intervention
Title
cardiorespiratory fitness; oxygen consumption during exercise - post intervention
Description
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.
Time Frame
Assessment will be conducted immediately after the intervention
Title
distance walked - baseline
Description
The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.
Time Frame
Assessment will be conducted before the intervention
Title
distance walked - post-intervention
Description
The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.
Time Frame
Assessment will be conducted immediately after the intervention
Title
information processing speed; cognitive function - baseline
Description
The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.
Time Frame
Assessment will be conducted before the intervention
Title
information processing speed; cognitive function - post intervention
Description
The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.
Time Frame
Assessment will be conducted immediately after the intervention
Title
volume of subcortical grey matter brain structures - baseline
Description
An MRI will be conducted to measure brain structure.
Time Frame
Assessment will be conducted before the intervention
Title
volume of subcortical grey matter brain structures - post intervention
Description
An MRI will be conducted to measure brain structure.
Time Frame
Assessment will be conducted immediately after the intervention
Title
resting state functional brain connectivity - baseline
Description
An MRI will be conducted to measure brain function.
Time Frame
Assessment will be conducted before the intervention
Title
resting state functional brain connectivity - post intervention
Description
An MRI will be conducted to measure brain function.
Time Frame
Assessment will be conducted immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Motl, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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