Clinical trial NCT01837017: Project FARMS: Fall Risk Reduction in Multiple Sclerosis
Official title: Project FARMS: Fall Risk Reduction in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Falls,
Balance,
Gait,
Older adults
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 33
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: 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.

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.

Primary outcomes:
measure: Physiological Fall risk
timeFrame: 3 months
Secondary outcomes:
measure: Mobility
timeFrame: 3 months
measure: Balance
timeFrame: 3 Months
measure: Spasticity
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 UC
name: Jacob Sosnoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.