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Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior (FARMS-2)

U

University of Illinois at Urbana-Champaign

Status and phase

Completed
Phase 2
Phase 1

Conditions

Multiple Sclerosis
Adult Disease

Treatments

Behavioral: Education
Behavioral: Home-based exercise
Behavioral: Exercise plus Education

Study type

Interventional

Funder types

Other

Identifiers

NCT01956227
NMSS-IL-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

37 participants in 4 patient groups

Home-based Exercise
Experimental group
Description:
Participants will be taught a series of exercises targeting balance and lower limb strength in four instructional sessions. They will be asked to complete exercises 3 times a week for 12 weeks. Exercise compliance will be recorded with a diary.
Treatment:
Behavioral: Home-based exercise
Education
Experimental group
Description:
Participants will attend 4 education sessions focusing on interaction of beliefs, behaviors and symptoms on falls. They will be taught self-management principles to modify their fall risk.
Treatment:
Behavioral: Education
Exercise plus education
Experimental group
Description:
Participants will attend 2 instructional exercise sessions as well as 2 education sessions. Participants will be asked to complete exercises at home 3 times per week and engage in behavior to minimize fall risk.
Treatment:
Behavioral: Exercise plus Education
Control
No Intervention group
Description:
Participants will not receive any treatment.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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