Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis (MS)
• Interventions: Behavioral: Physical activity behavioral intervention in persons newly diagnosed with MS

• Registration Number: NCT05641532
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-07
• Study Start: 2023-01-17
• Status Verified: 2023-08
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• ≥ 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention	Physical activity behavioral intervention in persons newly diagnosed with MS	This is a 1-arm study with an intervention condition based on the COM-B model

Primary Outcome Measures

Name	Time	Method
Feasibility metric: Process	12 weeks	Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures
Feasibility metric: Management	12 weeks	Management assesses data management.
Feasibility metric: Overall safety	12 weeks	Overall safety will be assessed through the number of adverse events.
Feasibility metric: Resource	12 weeks	We will assess the resources required for the study.
Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks	12 weeks	Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
Change of Physical Activity levels through Accelerometry from baseline and 12 weeks	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
Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks	12 weeks	Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks	12 weeks	Self report measures of quality of life will be assessed through the Multiple Sclerosis Impact Scale-29.Participants will complete this questionnaire at baseline and 12 weeks
Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks	12 weeks	Self report measures of fatigue will be assessed through the Fatigue Severity Scale. Participants will complete this questionnaire at baseline and 12 weeks
Formative evaluation	12 weeks	Participants' satisfaction in the study will be assessed through a self-developed survey which will be completed at 12 week.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States