NCT01837017

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1 multiple-sclerosis

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

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

April 17, 2013

Last Update Submit

November 23, 2014

Conditions

Multiple Sclerosis

Keywords

Falls,Balance,Gait,Older adults

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Mobility

    3 months

  • Balance

    3 Months

  • Spasticity

    3 Months

Study Arms (2)

Home-based Exercise

EXPERIMENTAL

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.

Behavioral: Home-based Exercise

Control

NO INTERVENTION

Wait-list control.

Interventions

Home-based ExerciseBEHAVIORAL

This is a control group with no intervention

Home-based Exercise

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • non-ambulatory;
  • risk factors contra-indicative for undertaking strenuous exercise as determined by the physical activity readiness questionnaire.

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, 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.

    PMID: 23983091RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jacob Sosnoff, PhD

    University of Illinois at UC

    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

April 22, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

US(1)