Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

NCT05641532 | Completed

• 1 other identifier: IRB-300009893
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video conferencing, for promoting physical activity and secondarily reducing fatigue and quality of life in persons newly diagnosed with MS (diagnosed with MS within the past 2 years). The investigators hypothesize the proposed 12-week intervention will be feasible based on process, resource, management, and scientific outcomes. The investigators further hypothesize that individuals who receive the 12-week intervention will demonstrate an increase in physical activity behavior, particularly daily step counts, and reduce fatigue.

Conditions

Multiple Sclerosis (MS)

Keywords

Physical activity; Newly diagnosed with MS; Behavior change; Multiple sclerosis

Outcome Measures

Primary Outcomes (7)

• Feasibility metric: Process

  Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures

  12 weeks

• Feasibility metric: Resource

  We will assess the resources required for the study.

  12 weeks

• Feasibility metric: Management

  Management assesses data management.

  12 weeks

• Feasibility metric: Overall safety

  Overall safety will be assessed through the number of adverse events.

  12 weeks

• Change of Physical Activity levels through Accelerometry from baseline and 12 weeks

  Physical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a belt around their waist during the waking hours of a 7 day period. Participants will complete this at baseline and 12 weeks

  12 weeks

• Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks

  Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.

  12 weeks

• Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks

  Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.

  12 weeks

Secondary Outcomes (3)

• Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks

  12 weeks

• Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks

  12 weeks

• Formative evaluation

  12 weeks

Study Arms (1)

Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention

EXPERIMENTAL

This is a 1-arm study with an intervention condition based on the COM-B model

Behavioral: Physical activity behavioral intervention in persons newly diagnosed with MS

Interventions

Physical activity behavioral intervention in persons newly diagnosed with MS BEHAVIORAL

1. The newsletters will provide the knowledge, skills, resources, and strategies for promoting physical activity in persons newly diagnosed with MS. These newsletters will be released seven times during the program. The first three newsletters will be released weekly, and the last four will be released every other week. 2. The one-on-one video coaching chats with participants will be conducted via Zoom, which consist of discussion and elaboration of newsletters content, supportive accountability, feedback and encouragement on behavior change. The chats further provide social persuasion for promoting behavior change. The chats are semi-scripted and individualized interventions (\~15 - 30 minutes/chat). The chats will occur seven times during the week when a newsletter is delivered. 3. The intervention includes a pedometer (NL-800 pedometer), a logbook, and a calendar for tracking daily step counts, planning of physical activity, setting goals, and monitoring progress over the program.

Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old
• Diagnosed with multiple sclerosis for 2 or fewer years
• Fully ambulatory
• No relapse within the last 30 days
• Non-active (Godin Leisure-Time Exercise Questionnaire - Health Contribution Score \< 14)
• Able to read 14-point font size
• Internet \& video conferencing access
• Undergoing disease-modifying therapy

You may not qualify if:

• Pregnancy
• Moderate or high risk for undertaking physical activity (≥ 2 affirmatives on the Physical Activity Readiness Questionnaire)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, 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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Advisor

Model Details: All participants will undergo one intervention condition remotely delivered using electronic newsletters and one-on-one video coaching. Outcome measures will be assessed at two time points: baseline and post-intervention.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 7, 2022
• Study Start: January 17, 2023
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)