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

February 2, 2022 updated by: Robert W Motl, University of Alabama at Birmingham

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Minutes of moderate to vigorous physical activity - Baseline
Time Frame: 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.
Assessment will be conducted before the intervention
Minutes of moderate to vigorous physical activity - Post intervention
Time Frame: 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.
Assessment will be conducted immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cardiorespiratory fitness; oxygen consumption during exercise - baseline
Time Frame: 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.
Assessment will be conducted before the intervention
cardiorespiratory fitness; oxygen consumption during exercise - post intervention
Time Frame: 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.
Assessment will be conducted immediately after the intervention
distance walked - baseline
Time Frame: 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.
Assessment will be conducted before the intervention
distance walked - post-intervention
Time Frame: 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.
Assessment will be conducted immediately after the intervention
information processing speed; cognitive function - baseline
Time Frame: 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.
Assessment will be conducted before the intervention
information processing speed; cognitive function - post intervention
Time Frame: 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.
Assessment will be conducted immediately after the intervention
volume of subcortical grey matter brain structures - baseline
Time Frame: Assessment will be conducted before the intervention
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
Time Frame: Assessment will be conducted immediately after the intervention
An MRI will be conducted to measure brain structure.
Assessment will be conducted immediately after the intervention
resting state functional brain connectivity - baseline
Time Frame: Assessment will be conducted before the intervention
An MRI will be conducted to measure brain function.
Assessment will be conducted before the intervention
resting state functional brain connectivity - post intervention
Time Frame: Assessment will be conducted immediately after the intervention
An MRI will be conducted to measure brain function.
Assessment will be conducted immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Motl, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Behavioral Intervention for Physical Activity in MS (BIPAMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings