Multiple SclerosisFIRMSNCT02314585
Fall Risk Reduction in Multiple Sclerosis (FIRMS)
A study testing Exercise and Education in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
This study looks to see the effects of a home based exercise program on falls in people with MS. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Motor control research lab
Urbana, Illinois, 61801
Jen Wajda, BS, 217-330-1696, jwajda@illinois.edu
About this study
Official title: Fall Risk Reduction in Multiple Sclerosis: Exercise Intervention vs. Attention Control Modification
This study looks to see the effects of a home based exercise program on falls in people with MS.
Read the 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
- Being tested
- Exercise, Education
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Education | Other | In the second phase, participants will partake in an instructional class relating to gait, balance, and falls. Receives: Other: Education |
| Exercise | Other | In the second phase,participants will partake in an exercise course relating to gait, balance, and falls. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chagne in Fall Risk
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.
Measured: 1 year
Secondary outcomes (1)
Identification of Fall Risk Factors
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob J Sosnoff, PhD, Principal investigator, Motor Control Lab, University of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314585
- Sponsor's protocol ID
- 15053
- Acronym
- FIRMS
- Status last verified
- Aug 2015
- First submitted
- 23 Nov 2014
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Risk Reduction in Multiple Sclerosis: Exercise Intervention vs. Attention Control Modification
- ClinicalTrials.gov ID
- NCT02314585
- Acronym / sponsor ID
- FIRMS / 15053
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Other | Other: EducationIn the second phase, participants will partake in an instructional class relating to gait, balance, and falls. |
| Exercise | Other | Other: ExerciseIn the second phase,participants will partake in an exercise course relating to gait, balance, and falls. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants 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. | Other | Exercise |
| EducationParticipants 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. | Other | Education |
Primary outcome
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.
1 secondary outcome
Identification of Fall Risk Factors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob J Sosnoff, PhD principal investigator
Motor Control Lab, University of Illinois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Education in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jen Wajda, BS (217-300-1696, jwajda@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chagne in Fall Risk (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.