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Completed

NCT Number: NCT04496804

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Intervention for Physical Activity in MS (BIPAMS)

Behavioral

A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.

Wellness for MS (WellMS)

Behavioral

A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. resting state functional brain connectivity - baseline

    Time frame: Assessment will be conducted before the intervention

    An MRI will be conducted to measure brain function.

  10. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: BIPAMS-Brain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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