Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Behavioral: WELLMS; Behavioral: BIPAMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03490240

170609001

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

BIPAMS

Experimental group

Description:

The behavioral intervention consists of two primary components, a dedicated Internet website and one-on-one video chats with a behavioral coach via Skype. The behavioral intervention focuses on the skills, techniques, resources, and strategies for becoming and staying physically active with MS, but it does not provide a prescription for exercise or physical activity itself.

Treatment:

Behavioral: BIPAMS

WELLMS

Active Comparator group

Description:

The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.

Treatment:

Behavioral: WELLMS