NCT01956227

Brief Summary

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

1.4 years

First QC Date

April 17, 2013

Last Update Submit

November 23, 2014

Conditions

Multiple SclerosisAdult Disease

Outcome Measures

Primary Outcomes (1)

  • Fall incidence

    3 months

Secondary Outcomes (3)

  • Physiological Fall Risk

    3 Months

  • Mobility

    3 months

  • Balance

    3 Months

Study Arms (4)

Home-based Exercise

EXPERIMENTAL

Participants will be taught a series of exercises targeting balance and lower limb strength in four instructional sessions. They will be asked to complete exercises 3 times a week for 12 weeks. Exercise compliance will be recorded with a diary.

Behavioral: Home-based exercise

Education

EXPERIMENTAL

Participants will attend 4 education sessions focusing on interaction of beliefs, behaviors and symptoms on falls. They will be taught self-management principles to modify their fall risk.

Behavioral: Education

Exercise plus education

EXPERIMENTAL

Participants will attend 2 instructional exercise sessions as well as 2 education sessions. Participants will be asked to complete exercises at home 3 times per week and engage in behavior to minimize fall risk.

Behavioral: Exercise plus Education

Control

NO INTERVENTION

Participants will not receive any treatment.

Interventions

Home-based exerciseBEHAVIORAL

exercise to look at balance and lower limb strength record in diary

Home-based Exercise
EducationBEHAVIORAL

sessions to discuss self-management ideas to modify risk of falling

Education
Exercise plus EducationBEHAVIORAL

combination of exercise sessions with education sessions to modify fall risk

Exercise plus education

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Definite multiple sclerosis diagnosis
  • ambulatory
  • aged 50-75 years of age
  • fallen within 12 months

You may not qualify if:

  • non-ambulatory
  • outside age range
  • no fall history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois UC

Urbana, Illinois, 61802, United States

Location

Related Publications (1)

  • Sosnoff JJ, Moon Y, Wajda DA, Finlayson ML, McAuley E, Peterson EW, Morrison S, Motl RW. Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial. Clin Rehabil. 2015 Oct;29(10):952-60. doi: 10.1177/0269215514564899. Epub 2014 Dec 23.

    PMID: 25540170DERIVED

MeSH Terms

Conditions

Multiple SclerosisDisease

Interventions

Educational StatusExercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jacob Sosnoff

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

October 8, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

US(1)