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

Primary Purpose

Multiple Sclerosis, Adult Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Home-based exercise
Education
Exercise plus Education
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Illinois UC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Home-based Exercise

Education

Exercise plus education

Control

Arm 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.

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.

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.

Participants will not receive any treatment.

Outcomes

Primary Outcome Measures

Fall incidence

Secondary Outcome Measures

Physiological Fall Risk
Physiological fall risk will be determined by the short form of the Physiological Profile Assessment (PPA)(Lord, 2003). The PPA is a standardized test battery which assesses vision (edge contrast sensitivity), lower limb proprioception, strength (knee extension), postural sway, and cognitive function (simple hand reaction time). The outcome of each test will be combined to generate an overall fall risk score
Mobility
Specific measures of walking speed, endurance, coordination and self-reported walking function scale will be employed to assess overall mobility of each person. Walking speed was quantified with the Timed 25-Foot Walk (T25W), walking endurance was assessed with the 6-Minute Walk (6MW), and functional mobility was quantified with the Timed Up and Go (TUG) . The Multiple Sclerosis Walking Scale-12 (MSWS-12) will be used as a self-reported measure of walking impairment.
Balance
To assess balance (e.g. postural control), we conducted a clinical assessment To measure balance the Berg Balance Scale (BBS) and self-reports of balance confidence will be used. The BBS is a clinical assessment of balance. Scores on the BBS range from 0-56 with higher scores indicating greater balance. The Activities-Specific Balance Confidence (ABC) scale was used as a measure of balance confidence.

Full Information

First Posted
April 17, 2013
Last Updated
November 23, 2014
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT01956227
Brief Title
Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior
Acronym
FARMS-2
Official Title
Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Adult Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-based Exercise
Arm Type
Experimental
Arm 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.
Arm Title
Education
Arm Type
Experimental
Arm 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.
Arm Title
Exercise plus education
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not receive any treatment.
Intervention Type
Behavioral
Intervention Name(s)
Home-based exercise
Intervention Description
exercise to look at balance and lower limb strength record in diary
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
sessions to discuss self-management ideas to modify risk of falling
Intervention Type
Behavioral
Intervention Name(s)
Exercise plus Education
Intervention Description
combination of exercise sessions with education sessions to modify fall risk
Primary Outcome Measure Information:
Title
Fall incidence
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Physiological Fall Risk
Description
Physiological fall risk will be determined by the short form of the Physiological Profile Assessment (PPA)(Lord, 2003). The PPA is a standardized test battery which assesses vision (edge contrast sensitivity), lower limb proprioception, strength (knee extension), postural sway, and cognitive function (simple hand reaction time). The outcome of each test will be combined to generate an overall fall risk score
Time Frame
3 Months
Title
Mobility
Description
Specific measures of walking speed, endurance, coordination and self-reported walking function scale will be employed to assess overall mobility of each person. Walking speed was quantified with the Timed 25-Foot Walk (T25W), walking endurance was assessed with the 6-Minute Walk (6MW), and functional mobility was quantified with the Timed Up and Go (TUG) . The Multiple Sclerosis Walking Scale-12 (MSWS-12) will be used as a self-reported measure of walking impairment.
Time Frame
3 months
Title
Balance
Description
To assess balance (e.g. postural control), we conducted a clinical assessment To measure balance the Berg Balance Scale (BBS) and self-reports of balance confidence will be used. The BBS is a clinical assessment of balance. Scores on the BBS range from 0-56 with higher scores indicating greater balance. The Activities-Specific Balance Confidence (ABC) scale was used as a measure of balance confidence.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Sosnoff
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois UC
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25540170
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.
Results Reference
derived

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Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior

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