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

NCT ID: NCT04496804

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2021-11-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral Intervention for Physical Activity in MS (BIPAMS)

Intervention Type: 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)

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.

Group Type: SHAM_COMPARATOR

Wellness for MS (WellMS)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Robert W Motl

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Motl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

300005111

Identifier Type: -

Identifier Source: org_study_id