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Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis (MS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity behavioral intervention in persons newly diagnosed with MS
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis (MS) focused on measuring Physical activity, Newly diagnosed with MS, Behavior change, Multiple sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility metric: Process
Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures
Feasibility metric: Resource
We will assess the resources required for the study.
Feasibility metric: Management
Management assesses data management.
Feasibility metric: Overall safety
Overall safety will be assessed through the number of adverse events.
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
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.
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.

Secondary Outcome Measures

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
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
Formative evaluation
Participants' satisfaction in the study will be assessed through a self-developed survey which will be completed at 12 week.

Full Information

First Posted
November 14, 2022
Last Updated
August 15, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05641532
Brief Title
Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis
Official Title
Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
August 8, 2023 (Actual)
Study Completion Date
August 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS)
Keywords
Physical activity, Newly diagnosed with MS, Behavior change, Multiple sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention
Arm Type
Experimental
Arm Description
This is a 1-arm study with an intervention condition based on the COM-B model
Intervention Type
Behavioral
Intervention Name(s)
Physical activity behavioral intervention in persons newly diagnosed with MS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility metric: Process
Description
Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures
Time Frame
12 weeks
Title
Feasibility metric: Resource
Description
We will assess the resources required for the study.
Time Frame
12 weeks
Title
Feasibility metric: Management
Description
Management assesses data management.
Time Frame
12 weeks
Title
Feasibility metric: Overall safety
Description
Overall safety will be assessed through the number of adverse events.
Time Frame
12 weeks
Title
Change of Physical Activity levels through Accelerometry from baseline and 12 weeks
Description
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
Time Frame
12 weeks
Title
Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks
Description
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
Time Frame
12 weeks
Title
Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks
Description
Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks
Description
Self report measures of fatigue will be assessed through the Fatigue Severity Scale. Participants will complete this questionnaire at baseline and 12 weeks
Time Frame
12 weeks
Title
Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks
Description
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
Time Frame
12 weeks
Title
Formative evaluation
Description
Participants' satisfaction in the study will be assessed through a self-developed survey which will be completed at 12 week.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

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