Fall Risk Reduction in Multiple Sclerosis (FIRMS)

NCT ID: NCT02314585

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-01-31

Brief Summary

This study looks to see the effects of a home based exercise program on falls in people with MS.

Detailed Description

The purposes of this project are four-fold: 1) to determine if a 6-month home-based targeted exercise program results in immediate and sustained reduction in falls risk and incidence ; 2) to identify the factors that contribute to a reduction in fall risk and incidence; 3) to determine if a decrease in physiological fall risk and/or fall incidence results in increased quality of life and participation in older adults with MS; and 4) to determine the association between cognition, environment and comorbidities on future falls and intervention efficacy.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Education

In the second phase, participants will partake in an instructional class relating to gait, balance, and falls.

Group Type: OTHER

Education

Intervention Type: OTHER

Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.

Exercise

In the second phase,participants will partake in an exercise course relating to gait, balance, and falls.

Group Type: OTHER

Exercise

Intervention Type: OTHER

Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.

Interventions

Exercise

Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.

Intervention Type: OTHER

Education

Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ability to walk 25 feet with or without aid
• Relapse free in the last 30 days
• Being ≥ 50 years of age
• Having fallen at least once in the past year
• Physician approval to engage in light physical activity
• Willingness and ability to attend the training sessions and testing sessions.

Exclusion Criteria

• We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise.
• During the initial phone contact with the project coordinator, participants will verbally respond to a health history questionnaire.
• Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 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 J Sosnoff, PhD

Role: PRINCIPAL_INVESTIGATOR

Motor Control Lab, University of Illinois

Locations

Motor control research lab

Urbana, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jen Wajda, BS

Role: CONTACT

jwajda@illinois.edu

217-300-1696

Facility Contacts

Jen Wajda, BS

Role: primary

jwajda@illinois.edu

217-330-1696

Other Identifiers

15053

Identifier Type: -

Identifier Source: org_study_id