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Completed

NCT Number: NCT05641532

Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physical activity behavioral intervention in persons newly diagnosed with MS

Behavioral
  • 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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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