Project FARMS: Fall Risk Reduction in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— FARMS-1  

Official title:

Project FARMS: Fall Risk Reduction in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837017
• Other study ID #: CMSC-2012
• Secondary ID: CMSC 2011-06476
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2013
• Last updated: November 23, 2014
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2014
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Home-based Exercise
This is a control group with no intervention

Locations

Country	Name	City	State
United States	University of Illinois UC	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	Yes
Secondary	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.	3 months	No
Secondary	Balance	Balance will be quantified with the Berg Balance scale; self-report of balance impairment (ABC); and force platform metrics (sway range and velocity).	3 Months	No
Secondary	Spasticity	Spasticity will be assessed with the modified ashworth scale.	3 Months	No