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Fall Risk Reduction in Multiple Sclerosis (FIRMS) (FIRMS)

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ClinicalTrials.gov Identifier: NCT02314585
Recruitment Status : Unknown
Verified August 2015 by University of Illinois at Urbana-Champaign.
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Exercise Other: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Fall Risk Reduction in Multiple Sclerosis: Exercise Intervention vs. Attention Control Modification
Study Start Date : December 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Education
In the second phase, participants will partake in an instructional class relating to gait, balance, and falls.
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.

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




Primary Outcome Measures :
  1. Chagne in Fall Risk [ Time Frame: 1 year ]
    The primary outcome measure of this investigation is physiological fall risk. Physiological fall risk will be determined by the short form of the physiological profile assessment (PPA). The PPA is a validated tool to assess physiological function related to fall risk by combining measures of vision, proprioception, lower-limb strength, postural sway, and cognitive function. It is predictive of future fall risk in persons with MS. The PPA provides a fall risk score that is based on the quantification of key physiological markers (e.g. vision, leg strength, proprioception, balance, cognition, etc) and comparison of those markers to age and gender matched normative data. The PPA provides a therapeutically relevant prognostic predictor of falls and this makes it an ideal outcome measure of investigations evaluating fall prevention strategies.


Secondary Outcome Measures :
  1. Identification of Fall Risk Factors [ Time Frame: 1 year ]
    The secondary outcome of fall incidence will be monitored prospectively for 6 months prior to and immediately following the 24 week intervention period via a fall diary A fall will be defined as an event where an individual unintentionally comes to the ground. Participants will receive a biweekly phone call and weekly text to inquire if they have suffered a fall and to remind them to complete the diary. If a fall is reported details of falls, information about injury, and other pertinent information will be attained. The fall diary will be contained in a brightly labeled binder and participants will be asked to mark if they have or have not fallen on a given day. At the end of each month participants will mail the dairy back in a preaddressed prepaid envelope to the research lab. The fall calls/diary will allow for the determination of number of falls, and fall rate per person year.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria involve having an established definite diagnosis of MS
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314585


Contacts
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Contact: Jen Wajda, BS 217-300-1696 jwajda@illinois.edu

Locations
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United States, Illinois
Motor control research lab Recruiting
Urbana, Illinois, United States, 61801
Contact: Jen Wajda, BS    217-330-1696    jwajda@illinois.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Jacob J Sosnoff, PhD Motor Control Lab, University of Illinois

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02314585     History of Changes
Other Study ID Numbers: 15053
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases