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Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05641532
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Elizabeth Barstow, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis (MS) Behavioral: Physical activity behavioral intervention in persons newly diagnosed with MS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
Actual Study Start Date : January 17, 2023
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention
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
  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.




Primary Outcome Measures :
  1. Feasibility metric: Process [ Time Frame: 12 weeks ]
    Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures

  2. Feasibility metric: Resource [ Time Frame: 12 weeks ]
    We will assess the resources required for the study.

  3. Feasibility metric: Management [ Time Frame: 12 weeks ]
    Management assesses data management.

  4. Feasibility metric: Overall safety [ Time Frame: 12 weeks ]
    Overall safety will be assessed through the number of adverse events.

  5. Change of Physical Activity levels through Accelerometry from baseline and 12 weeks [ Time Frame: 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

  6. Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks [ Time Frame: 12 weeks ]
    Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.

  7. Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks [ Time Frame: 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 :
  1. Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks [ Time Frame: 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

  2. Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks [ Time Frame: 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

  3. Formative evaluation [ Time Frame: 12 weeks ]
    Participants' satisfaction in the study will be assessed through a self-developed survey which will be completed at 12 week.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641532


Contacts
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Contact: Elizabeth A Barstow, Ph.D. (205)934-7321 bbarstow@uab.edu
Contact: Le Thao Trinh Huynh, MPH (205) 975-1306 trinhhlt@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35205
Contact: Le Thao Trinh Huynh, MPH    205-975-1306      
Sponsors and Collaborators
University of Alabama at Birmingham
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Responsible Party: Elizabeth Barstow, Faculty Advisor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05641532    
Other Study ID Numbers: IRB-300009893
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Barstow, University of Alabama at Birmingham:
Physical activity
Newly diagnosed with MS
Behavior change
Multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases