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Completed

NCT Number: NCT01837017

Project FARMS: Fall Risk Reduction in Multiple Sclerosis

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Illinois UC

Urbana, Illinois, 61802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-Based Exercise

Behavioral

This is a control group with no intervention

Primary outcomes

  1. Physiological Fall risk

    Time frame: 3 months

    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 outcomes

  1. Mobility

    Time frame: 3 months

    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.

  2. Balance

    Time frame: 3 Months

    Balance will be quantified with the Berg Balance scale; self-report of balance impairment (ABC); and force platform metrics (sway range and velocity).

  3. Spasticity

    Time frame: 3 Months

    Spasticity will be assessed with the modified ashworth scale.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Acronym: FARMS-1

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 22, 2013
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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