Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis

NCT06355804 | Active Not Recruiting

• 1 other identifier: STUDY2023-1565
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years). Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention. Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition.

Conditions

Multiple Sclerosis

Keywords

Physical activity; Behavior change; Behavioral intervention

Outcome Measures

Primary Outcomes (5)

• Physical Activity Behavior

  Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.

  Changes in the GLTEQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Physical Activity Behavior

  International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.

  Changes in the IPAQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Physical Activity Level (Light physical activity)

  Time (minutes/day) spent in light physical activity (LPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of LPA reflects a higher level of physical activity.

  Changes in time spent in LPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Physical Activity Level (Moderate-to-vigorous physical activity)

  Time (minutes/day) spent in moderate-to-vigorous physical activity (MVPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of MVPA reflects a higher level of physical activity.

  Changes in time spent in MVPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Physical Activity Level (Daily step count)

  Daily step count will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a greater number of steps per day reflects a higher level of physical activity.

  Changes in time spent in daily step count from Baseline (pre-intervention) and after 16 weeks (post-intervention)

Secondary Outcomes (5)

• Health-related quality of Life

  Changes in SF-12 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Health-related Quality of Life

  Changes in MSIS-29 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Fatigue Severity

  Changes in fatigue severity scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Depressive Symptoms

  Changes in depressive symptoms scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

• Anxiety

  Changes in anxiety scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

Study Arms (2)

Physical activity condition

EXPERIMENTAL

Participants in this arm will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15 - 30 minutes) over Zoom with a behavioral coach after the baseline assessment. Throughout the 16-week period, The investigators will ask participants to wear a Fitbit (provided) for tracking daily physical activity.

Behavioral: Physical activity condition

Waitlist condition

OTHER

Participants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15-30 minutes) over Zoom with a behavioral coach after the follow-up assessment.

Behavioral: Waitlist condition

Interventions

Physical activity condition BEHAVIORAL

Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: * The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels. * Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity. * The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS. * The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded.

Physical activity condition

Waitlist condition BEHAVIORAL

Participants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: * The newsletters provide information on the benefits of physical activity, goal setting and monitoring, and other behavioral strategies for increasing and maintaining physical activity levels. * The newsletter will be emailed to participants weekly throughout the program. * Content on the newsletter includes knowledge and skills related to physical activity in the early stages of MS, text of individuals with MS discussing their experiences, web links, worksheets, and brochures. * The program also involves 7 one-on-one video coaching chats with a behavioral coach to guide participants through the program and navigate challenges. These chats are conducted face- to-face over Zoom and generally last about 15 - 30 minutes each. The investigators do not record these sessions.

Waitlist condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• self-reported diagnosis of MS by a neurologist within the past 2 years
• relapse-free for the past 30 days
• ability to speak and read English as primary language
• internet and e-mail access, and willingness to complete the testing and questionnaires
• ambulatory without an assistive device (e.g., cane)
• insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) \< 14)
• visual ability and literacy to read newsletter with font size 14 points
• on a disease-modifying therapy.

You may not qualify if:

• pregnant
• have elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 9, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)