Clinical trial NCT01956227: Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior
Official title: Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Adult Disease
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.

Detailed description: Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear.

It is well known that causes of falls are multifactorial with over 400 risk factors identified. However, it is believed that these factors can be divided into two main classes: intrinsic (e.g. physiological factors) and extrinsic factors. For instance balance dysfunction, spasticity and muscle weakness are physiological risk factors for falls in MS . Behavioral fall risk factors in MS include choosing appropriate footwear, lighting and utilizing appropriate assistive device. There is evidence that both types of risk factors can be minimized with appropriately designed interventions in persons with MS and have been shown to reduce fall risk and incidence in other clinical populations. This has led to calls for the combination of exercise training program that targets specific, modifiable physiological risk factors and educational interventions targeting modifiable behavioral risk factors in persons with MS. However, there is minimal evidence that these interventions in isolation or combination actually reduce fall incidence or risk in persons with MS. This proposal seeks to determine the effectiveness of a combined exercise and educational rehabilitation strategy to prevent falls in persons with MS.

Eligibility criteria: Inclusion Criteria:

* Definite multiple sclerosis diagnosis
* ambulatory
* aged 50-75 years of age
* fallen within 12 months

Exclusion Criteria:

* non-ambulatory
* outside age range
* no fall history

Primary outcomes:
measure: Fall incidence
timeFrame: 3 months
Secondary outcomes:
measure: Physiological Fall Risk
timeFrame: 3 Months
measure: Mobility
timeFrame: 3 months
measure: Balance
timeFrame: 3 Months
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois UC
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Jacob Sosnoff
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sosnoff JJ, Moon Y, Wajda DA, Finlayson ML, McAuley E, Peterson EW, Morrison S, Motl RW. Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial. Clin Rehabil. 2015 Oct;29(10):952-60. doi: 10.1177/0269215514564899. Epub 2014 Dec 23.