Project FARMS: Fall Risk Reduction in Multiple Sclerosis

NCT ID: NCT01837017

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-03-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Home-based Exercise

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.

Group Type: EXPERIMENTAL

Home-based Exercise

Intervention Type: BEHAVIORAL

This is a control group with no intervention

Control

Wait-list control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home-based Exercise

This is a control group with no intervention

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Sosnoff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at UC

Locations

University of Illinois UC

Urbana, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23983091 (View on PubMed)

Other Identifiers

CMSC 2011-06476

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CMSC-2012

Identifier Type: -

Identifier Source: org_study_id