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Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis

The University of Alabama at Birmingham logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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