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

NCT04496804 | Completed

• 1 other identifier: 300005111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

physical activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• cardiorespiratory fitness; oxygen consumption during exercise - baseline

  Assessment will be conducted before the intervention

• cardiorespiratory fitness; oxygen consumption during exercise - post intervention

  Assessment will be conducted immediately after the intervention

• distance walked - baseline

  Assessment will be conducted before the intervention

• distance walked - post-intervention

  Assessment will be conducted immediately after the intervention

• information processing speed; cognitive function - baseline

  Assessment will be conducted before the intervention

Study Arms (2)

Behavioral Intervention for Physical Activity in MS (BIPAMS)

EXPERIMENTAL

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)

Wellness for MS (WellMS)

SHAM COMPARATOR

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)

Interventions

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.

Behavioral Intervention for Physical Activity in MS (BIPAMS)

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.

Wellness for MS (WellMS)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• moderate or high risk for undertaking strenuous or maximal exercise

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Behavior Therapy; Exercise; Health

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Population Characteristics

Study Officials

• Robert Motl, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: November 2, 2020
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: February 4, 2022

Record last verified: 2021-09

Locations

US (1)