Multiple SclerosisPhase 1FARMS-1NCT01837017
Project FARMS: Fall Risk Reduction in Multiple Sclerosis
A Phase 1 study testing Home-based Exercise in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Home-based Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2013
- Phase
- Phase 1
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-ambulatory;
- risk factors contra-indicative for undertaking strenuous exercise as determined by the physical activity readiness questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Over half of persons with multiple sclerosis (MS) report falling over a 6-month period and half of those who fall require medical attention for injuries. To make matters worse, a fall can result in activity curtailment, physiological deconditioning, and institutionalization. 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. To that end, an appropriately designed exercise training program that targets specific, modifiable risk factors might be effective for decreasing the fall risk in persons with MS.
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.
Participants will undergo multidimensional assessment of walking, balance, muscle strength, spasticity and fall risk prior to and immediately following the 12 week intervention. Following baseline assessment participants will be randomized into intervention or control groups. The intervention group will receive exercise instruction 4 times over 2 months. The home-based exercise protocol will focus on improving balance, walking, lower limb and core muscle strength, and spasticity, all potential determinants of falling.
- Conditions
- Multiple Sclerosis
- Being tested
- Home-based Exercise
- Keywords
- Falls,, Balance,, Gait,, Older adults
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based ExerciseBehavioural
This is a control group with no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Home-based Exercise |
| Control | No intervention | Wait-list control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Mobility
Mobility will be quantified with performance on timed 25 foot walk (T25W), timed up and go (TUG), Six spot step test, 6 minute walk and the MS walking scale-12.
Measured: 3 months
Balance
Balance will be quantified with the Berg Balance scale; self-report of balance impairment (ABC); and force platform metrics (sway range and velocity).
Measured: 3 Months
Spasticity
Spasticity will be assessed with the modified ashworth scale.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Sosnoff, PhD, Principal investigator, University of Illinois at UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837017
- Sponsor's protocol ID
- CMSC-2012
- Other IDs
- CMSC 2011-06476
- Acronym
- FARMS-1
- Status last verified
- Nov 2014
- First submitted
- 17 Apr 2013
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23983091
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project FARMS: Fall Risk Reduction in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01837017
- Acronym / sponsor ID
- FARMS-1 / CMSC-2012
- Conditions
- Multiple Sclerosis
- Keywords
- Falls,, Balance,, Gait,, Older adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Apr 2013 (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.
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.
Detailed description
Over half of persons with multiple sclerosis (MS) report falling over a 6-month period and half of those who fall require medical attention for injuries. To make matters worse, a fall can result in activity curtailment, physiological deconditioning, and institutionalization. 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. To that end, an appropriately designed exercise training program that targets specific, modifiable risk factors might be effective for decreasing the fall risk in persons with MS.
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.
Participants will undergo multidimensional assessment of walking, balance, muscle strength, spasticity and fall risk prior to and immediately following the 12 week intervention. Following baseline assessment participants will be randomized into intervention or control groups. The intervention group will receive exercise instruction 4 times over 2 months. The home-based exercise protocol will focus on improving balance, walking, lower limb and core muscle strength, and spasticity, all potential determinants of falling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Exercise | Experimental | Behavioral: Home-based ExerciseThe 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. |
| Control | No intervention | –Wait-list control. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- non-ambulatory;
- risk factors contra-indicative for undertaking strenuous exercise as determined by the physical activity readiness questionnaire.
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 |
|---|---|---|
| Home-based ExerciseThis is a control group with no intervention | Behavioural | Home-based Exercise |
Primary outcome
Physiological Fall risk
Time frame: 3 months
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 secondary outcomes
Mobility
Time frame: 3 months
Balance
Time frame: 3 Months
Spasticity
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
- Results publication: PubMed 23983091Sosnoff 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.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
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 Sosnoff, PhD principal investigator
University of Illinois at UC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Home-based Exercise 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 25 Nov 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Fall risk (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837017, which also lists 1 linked publication.
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 25 Nov 2014.