Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

Multiple Sclerosis (MS) Clinical Trial

Official title:

Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641532
• Other study ID #: IRB-300009893
• Status: Completed
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: August 8, 2023

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility metric: Resource	We will assess the resources required for the study.	12 weeks
Primary	Feasibility metric: Management	Management assesses data management.	12 weeks
Primary	Feasibility metric: Overall safety	Overall safety will be assessed through the number of adverse events.	12 weeks
Primary	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
Primary	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
Primary	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	Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 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	12 weeks
Secondary	Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 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	12 weeks
Secondary	Formative evaluation	Participants' satisfaction in the study will be assessed through a self-developed survey which will be completed at 12 week.	12 weeks