Clinical trial NCT05641532: Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis
Official title: Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis (MS)
Keywords: Physical activity
Newly diagnosed with MS
Behavior change
Multiple sclerosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Feasibility metric: Process
timeFrame: 12 weeks
measure: Feasibility metric: Resource
timeFrame: 12 weeks
measure: Feasibility metric: Management
timeFrame: 12 weeks
measure: Feasibility metric: Overall safety
timeFrame: 12 weeks
measure: Change of Physical Activity levels through Accelerometry from baseline and 12 weeks
timeFrame: 12 weeks
measure: Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks
timeFrame: 12 weeks
measure: Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks
timeFrame: 12 weeks
measure: Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks
timeFrame: 12 weeks
measure: Formative evaluation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: