Clinical trial NCT03490240: Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis
Official title: Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2018-04-06
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS
* Relapse free in the past 30 days
* Internet and email access
* Willingness to complete the questionnaires, wear the accelerometer, and undergo randomization
* Being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months
* Ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair)
* Age between 18 and 64

Exclusion Criteria:

* Moderate or high risk for undertaking strenuous or maximal exercise per participants response to the PAR-Q. Those who report no more than one YES or affirmative on the 7 item PAR-Q will be considered at low risk and included for participation. All others will be considered at moderate or high risk and excluded from participation.

Primary outcomes:
measure: Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months.
timeFrame: Baseline through 12 months
measure: Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline at 6 and 12 months.
timeFrame: Baseline through 12 months.
measure: Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline at 6 and 12 months.
timeFrame: Baseline through 12 months.
Secondary outcomes:
measure: Change of self-report measures of walking through the Multiple Sclerosis Walking Scale - 12 from baseline at 6 and 12 months
timeFrame: Baseline through 12 months
measure: Change of self-report measures of Walking through the Patient Determined Disease Steps Scale from baseline at 6 and 12 months.
timeFrame: Baseline through 12 months
measure: Change of self-report measures of Cognition through the Perceived Deficits Questionnaire from baseline at 6 and 12 months.
timeFrame: Baseline through 12 months
measure: Change of self-report measures of Cognition through the Multiple Sclerosis Neuropsychological Questionnaire from baseline at 6 and 12 months.
timeFrame: Baseline through 12 months
measure: Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline at 6 and 12 months.
timeFrame: Baseline through 12 months
measure: Change of self-report measures of Fatigue through the Modified Fatigue Impact Scale at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Change of self-report measures of Anxiety and Depression through the Hospital Anxiety and Depression Scale at 6 months and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Change of self-report measures of Pain through the Short-form of McGill Pain Questionnaire at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures of sleep through the Pittsburgh Sleep Quality Index at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures of quality of life through the Medical Outcomes Study Short Form-36 at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
Other outcomes:
measure: Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the MS Self-Efficacy Sale at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the Exercise Self-Efficacy Scale at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures based on goal setting through the Exercise Goal Setting and Planning Scale at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures based on outcome expectations through the Multidimensional Outcome Expectancies for Exercise Scale at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures based on quality of life through the Late-Life Function and Disability Inventory at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
measure: Changes of self-report measures based on quality of life through the Social Provisions Scale Inventory at 6 and 12 months from baseline.
timeFrame: Baseline through 12 months
Locations:
city: Birmingham
country: United States
facility: Exercise Neuroscience Research Lab
state: Alabama
Study officials:
affiliation: Associate Professor
name: Donald Lein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silveira SL, McCroskey J, Wingo BC, Motl RW. eHealth-Based Behavioral Intervention for Increasing Physical Activity in Persons With Multiple Sclerosis: Fidelity Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Mar 1;8(3):e12319. doi: 10.2196/12319.