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Project FARMS: Fall Risk Reduction in Multiple Sclerosis (FARMS-1)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Home-based Exercise
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 focused on measuring Falls,, Balance,, Gait,, Older adults

Eligibility Criteria

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

Inclusion Criteria:

  • having an established definite diagnosis of MS;
  • being independently ambulatory or ambulatory with an aid;
  • having the visual ability necessary to read 14 point font;
  • meeting the age requirement (i.e., 50-75 years of age);
  • having fallen at least once in the past year and
  • willingness and ability to attend the training sessions and testing sessions

Exclusion Criteria:

  • non-ambulatory;
  • risk factors contra-indicative for undertaking strenuous exercise as determined by the physical activity readiness questionnaire.

Sites / Locations

  • University of Illinois UC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home-based Exercise

Control

Arm Description

The home-based exercise group attends 4 exercise instructional sessions lead by a train exercise specialist. The exercise protocol focuses on improving balance, walking, lower limb and core muscle strength, and spasticity. The instructional session teaches participants a standardized series of exercises that focus on balance, muscle strength, and stretching. The exercises target lower limb & core muscle function. Once taught, participants will perform the exercises 3 times a week in their home as outlined in a manual. Subjects return in the first month and second month to ensure that exercises are being executed with correct form and appropriate intensity level. Compliance of at-home exercise will be assessed with diaries that participants complete every other week.

Wait-list control.

Outcomes

Primary Outcome Measures

Physiological Fall risk
Physiological fall risk will be determined by the physiological profile assessment which assesses physiological function related to fall risk by combining measures of vision, proprioception, lower-limb strength, postural sway, and cognitive function.

Secondary Outcome Measures

Mobility
Mobility will be quantified with performance on timed 25 foot walk (T25W), timed up and go (TUG), Six spot step test, 6 minute walk and the MS walking scale-12.
Balance
Balance will be quantified with the Berg Balance scale; self-report of balance impairment (ABC); and force platform metrics (sway range and velocity).
Spasticity
Spasticity will be assessed with the modified ashworth scale.

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
NCT01837017
Brief Title
Project FARMS: Fall Risk Reduction in Multiple Sclerosis
Acronym
FARMS-1
Official Title
Project FARMS: Fall Risk Reduction in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (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
Over half of persons with multiple sclerosis (MS) report falling over a 6-month period and a majority of those who fall require medical attention for injuries. Importantly, balance dysfunction, muscle weakness, and spasticity are modifiable risk factors for falls among community-dwelling older adults and likely persons with MS. Indeed, there is evidence that these physiological risk factors can be minimized with exercise training in persons with MS and this might translate into a decrease in fall risk as documented in community-dwelling older adults. The investigation will examine the effectiveness of a home-based exercise program that is designed to reduce fall risk by targeting specific fall risk factors including balance dysfunction and two of its latent causes, muscle weakness and spasticity in persons with multiple sclerosis. It is predicted that persons who receive home-based exercise program will have a reduction in fall risk.
Detailed Description
Over half of persons with multiple sclerosis (MS) report falling over a 6-month period and half of those who fall require medical attention for injuries. To make matters worse, a fall can result in activity curtailment, physiological deconditioning, and institutionalization. Importantly, balance dysfunction, muscle weakness, and spasticity are modifiable risk factors for falls among community-dwelling older adults and likely persons with MS. Indeed, there is evidence that these physiological risk factors can be minimized with exercise training in persons with MS and this might translate into a decrease in fall risk as documented in community-dwelling older adults. To that end, an appropriately designed exercise training program that targets specific, modifiable risk factors might be effective for decreasing the fall risk in persons with MS. The investigation will examine the effectiveness of a home-based exercise program that is designed to reduce fall risk by targeting specific fall risk factors including balance dysfunction and two of its latent causes, muscle weakness and spasticity in persons with multiple sclerosis. It is predicted that persons who receive home-based exercise program will have a reduction in fall risk. Participants will undergo multidimensional assessment of walking, balance, muscle strength, spasticity and fall risk prior to and immediately following the 12 week intervention. Following baseline assessment participants will be randomized into intervention or control groups. The intervention group will receive exercise instruction 4 times over 2 months. The home-based exercise protocol will focus on improving balance, walking, lower limb and core muscle strength, and spasticity, all potential determinants of falling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Falls,, Balance,, Gait,, Older adults

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Home-based Exercise
Arm Type
Experimental
Arm Description
The home-based exercise group attends 4 exercise instructional sessions lead by a train exercise specialist. The exercise protocol focuses on improving balance, walking, lower limb and core muscle strength, and spasticity. The instructional session teaches participants a standardized series of exercises that focus on balance, muscle strength, and stretching. The exercises target lower limb & core muscle function. Once taught, participants will perform the exercises 3 times a week in their home as outlined in a manual. Subjects return in the first month and second month to ensure that exercises are being executed with correct form and appropriate intensity level. Compliance of at-home exercise will be assessed with diaries that participants complete every other week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait-list control.
Intervention Type
Behavioral
Intervention Name(s)
Home-based Exercise
Intervention Description
This is a control group with no intervention
Primary Outcome Measure Information:
Title
Physiological Fall risk
Description
Physiological fall risk will be determined by the physiological profile assessment which assesses physiological function related to fall risk by combining measures of vision, proprioception, lower-limb strength, postural sway, and cognitive function.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mobility
Description
Mobility will be quantified with performance on timed 25 foot walk (T25W), timed up and go (TUG), Six spot step test, 6 minute walk and the MS walking scale-12.
Time Frame
3 months
Title
Balance
Description
Balance will be quantified with the Berg Balance scale; self-report of balance impairment (ABC); and force platform metrics (sway range and velocity).
Time Frame
3 Months
Title
Spasticity
Description
Spasticity will be assessed with the modified ashworth scale.
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: having an established definite diagnosis of MS; being independently ambulatory or ambulatory with an aid; having the visual ability necessary to read 14 point font; meeting the age requirement (i.e., 50-75 years of age); having fallen at least once in the past year and willingness and ability to attend the training sessions and testing sessions Exclusion Criteria: non-ambulatory; risk factors contra-indicative for undertaking strenuous exercise as determined by the physical activity readiness questionnaire.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Sosnoff, PhD
Organizational Affiliation
University of Illinois at UC
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
23983091
Citation
Sosnoff JJ, Finlayson M, McAuley E, Morrison S, Motl RW. Home-based exercise program and fall-risk reduction in older adults with multiple sclerosis: phase 1 randomized controlled trial. Clin Rehabil. 2014 Mar;28(3):254-63. doi: 10.1177/0269215513501092. Epub 2013 Aug 27.
Results Reference
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Project FARMS: Fall Risk Reduction in Multiple Sclerosis

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