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| Name | Class |
|---|---|
| First Steps Wellness Centre | UNKNOWN |
| Saskatchewan Health Research Foundation | OTHER |
| University of Saskatchewan | OTHER |
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A growing body of work suggests that regular exercise can support symptom management and improve physical function for people living with multiple sclerosis (MS). Although exercise is known to be beneficial for managing many symptoms related to MS, its effects on the central nervous system, and whether these effects change with different types of exercise, are not well understood. Here, the investigators have designed a clinical trial that compares the effects of distinct exercise protocols on aspects of physical function, physical fitness, and central nervous system function. This research will be the first to compare the effects of different types of exercise on central nervous system changes in people with MS.
A total of 69 participants with multiple sclerosis (MS) and moderate motor disability in the province of Saskatchewan, Canada will be randomly assigned to receive one of three distinct exercise programs. All exercise programs will be delivered three times per week in 60-minute group sessions over the course of 12 weeks under the supervision of Clinical Exercise Physiologists. Exercise programming will include activities focused on mobility, fitness, and flexibility. Assessments of physical function, physical fitness, and central nervous system function will be conducted immediately before, after, and six weeks following completion of the exercise programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group 1 | Experimental | The intervention will focus on mobility and balance. |
|
| Exercise Group 2 | Active Comparator | This intervention will focus on physical fitness. |
|
| Exercise Group 3 | Sham Comparator | This intervention will focus on flexibility, range of motion, and muscle tone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Group 1 | Other | Prescribed exercises will focus on mobility and balance. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25-Foot Walk Test | The Timed 25-Foot Walk Test provides an assessment of mobility and lower-extremity function through a measurement of fast walking speed. Test scores range from 0-180 seconds with higher values indicating a worse outcome. | 6 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Evoked Potential Amplitude | Measuring the amplitude of motor evoked potentials elicited by transcranial magnetic stimulation delivered over the motor cortex provides information about corticospinal excitability. Corticospinal excitability is a potential marker of MS disease burden that is responsive to physical training in people with MS and has been used to study experience-dependent neuroplasticity in other neurological conditions. The range of response amplitude is 0-100% of maximal muscle fibre recruitment, with higher values indicating better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Balance Evaluation Systems Test | The Mini Balance Evaluation Systems Test provides an assessment of balance control systems. The Mini-BESTest has a high sensitivity in detecting balance impairments in people with MS. The Mini-BESTest has score values between 0-28 with a higher score meaning a better outcome. | 6 weeks post intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cameron Mang, PhD | Contact | 306-585-4066 | cameron.mang@uregina.ca |
| Name | Affiliation | Role |
|---|---|---|
| Cameron Mang, PhD | University of Regina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regina | Recruiting | Regina | Saskatchewan | S4S5N6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21172683 | Background | Warraich Z, Kleim JA. Neural plasticity: the biological substrate for neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S208-19. doi: 10.1016/j.pmrj.2010.10.016. | |
| 19884575 | Background | Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4. |
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No individual participant data will be shared with other researchers.
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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All interventions will involve 60-minute sessions delivered three times per week for 12 weeks. All interventions will involve the whole body but differ in content.
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Participants will not be informed of the different study arms. Interventions will be scheduled to avoid contact between study arms. Participants will be asked to not describe their activities to those outside of their exercise group. Although it will not be possible to blind program instructors from the intervention that they deliver, instructors will not be aware of the expected results. Assessors and data analysts will be fully blinded to study arm allocation.
| Exercise Group 2 |
| Other |
Prescribed exercises will focus on physical fitness. |
|
| Exercise Group 3 | Other | Prescribed exercises will focus on flexibility, range of motion, and muscle tone. |
|
| 6 weeks post intervention |
| Multiple Sclerosis Impact Scale |
The Multiple Sclerosis Impact Scale is a self-report survey that measures the impact of multiple sclerosis on physical and psychological functioning. The MSIS test has a score value between 0-145 with a higher score meaning a worse outcome. |
| 6 weeks post intervention |
| 9-Hole Pegboard Test | The 9-Hole Pegboard Test is a quantitative measure of upper extremity function. The test has a time limit of 300 seconds with higher values indicating a worse outcome. | 6 weeks post intervention |
| Symbol Digit Modalities Test | The Symbol Digit Modalities Test is used to asses divided attention, visual scanning, tracking and motor speed. The SDMT test is scored as the number of correct answers provided within 90 seconds (range: 0-110). A higher score would indicate a better outcome. | 6 weeks post intervention |
| Peak Isometric Hand Grip Force | Peak Isometric Hand Grip Force provides a measure of general upper-extremity strength. Values typically range from 0 to approximately 75 kilograms of force, with higher values indicating greater strength. | 6 weeks post intervention |
| Peak Isometric Knee Extensor Torque | Peak Isometric Knee Extensor Torque provides a measure of general lower-extremity strength. Values typically range from 0 to approximately 75 kg of force, with higher values indicating greater strength. Values typically range from 0 to approximately 300 Newton*Meters of torque, with higher values indicating greater strength. | 6 weeks post intervention |
| Peak Oxygen Uptake | Peak Oxygen Uptake provides a measure of cardiorespiratory fitness. It is measured through administration of a maximal exercise test. Values typically range from 0-90 milliliters per minute per kilogram. | 6 weeks post intervention |
| Tumor Necrosis Factor Alpha concentration in systemic blood | Tumor Necrosis Factor is an inflammatory cytokine that can be measured in human blood serum. Values typically range from 100 to 5000 picograms per milliliter of blood serum. Higher values are generally considered worse. | 6 weeks post intervention |
| Brain-Derived Neurotrophic Factor in systemic blood | Brain-Derived Neurotrophic Factor is a neurotrophic growth factor that can be measured in human blood serum. Values typically range from 15 to 80 nanograms per milliliter of blood serum. Higher values are generally considered better. | 6 weeks post intervention |
| Neurofilament Light concentration in systemic blood | Neurofilament Light is a neuronal cytoplasmic protein that can be measured in human blood serum. Values typically range from 0 to 100 picograms per milliliter of blood serum. Higher values are generally considered worse. | 6 weeks post intervention |
| 24174581 | Background | Goldman MD, Motl RW, Scagnelli J, Pula JH, Sosnoff JJ, Cadavid D. Clinically meaningful performance benchmarks in MS: timed 25-foot walk and the real world. Neurology. 2013 Nov 19;81(21):1856-63. doi: 10.1212/01.wnl.0000436065.97642.d2. Epub 2013 Oct 30. |
| 32168157 | Background | Chaves AR, Devasahayam AJ, Kelly LP, Pretty RW, Ploughman M. Exercise-Induced Brain Excitability Changes in Progressive Multiple Sclerosis: A Pilot Study. J Neurol Phys Ther. 2020 Apr;44(2):132-144. doi: 10.1097/NPT.0000000000000308. |
| 31636661 | Background | Snow NJ, Wadden KP, Chaves AR, Ploughman M. Transcranial Magnetic Stimulation as a Potential Biomarker in Multiple Sclerosis: A Systematic Review with Recommendations for Future Research. Neural Plast. 2019 Sep 16;2019:6430596. doi: 10.1155/2019/6430596. eCollection 2019. |
| 22740603 | Background | Kieseier BC, Pozzilli C. Assessing walking disability in multiple sclerosis. Mult Scler. 2012 Jul;18(7):914-24. doi: 10.1177/1352458512444498. Epub 2012 Apr 24. |
| 21436388 | Background | Phan-Ba R, Pace A, Calay P, Grodent P, Douchamps F, Hyde R, Hotermans C, Delvaux V, Hansen I, Moonen G, Belachew S. Comparison of the timed 25-foot and the 100-meter walk as performance measures in multiple sclerosis. Neurorehabil Neural Repair. 2011 Sep;25(7):672-9. doi: 10.1177/1545968310397204. Epub 2011 Mar 24. |
| 22073939 | Background | Coleman CI, Sobieraj DM, Marinucci LN. Minimally important clinical difference of the Timed 25-Foot Walk Test: results from a randomized controlled trial in patients with multiple sclerosis. Curr Med Res Opin. 2012 Jan;28(1):49-56. doi: 10.1185/03007995.2011.639752. Epub 2011 Nov 23. |
| 28206828 | Background | Motl RW, Cohen JA, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):704-710. doi: 10.1177/1352458517690823. Epub 2017 Feb 16. |
| 17507641 | Background | Yen CL, Wang RY, Liao KK, Huang CC, Yang YR. Gait training induced change in corticomotor excitability in patients with chronic stroke. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):22-30. doi: 10.1177/1545968307301875. Epub 2007 May 16. |
| 25000308 | Background | Guerra E, di Cagno A, Mancini P, Sperandii F, Quaranta F, Ciminelli E, Fagnani F, Giombini A, Pigozzi F. Physical fitness assessment in multiple sclerosis patients: a controlled study. Res Dev Disabil. 2014 Oct;35(10):2527-33. doi: 10.1016/j.ridd.2014.06.013. Epub 2014 Jul 5. |
| 26247510 | Background | Pilutti LA, Sandroff BM, Klaren RE, Learmonth YC, Platta ME, Hubbard EA, Stratton M, Motl RW. Physical Fitness Assessment Across the Disability Spectrum in Persons With Multiple Sclerosis: A Comparison of Testing Modalities. J Neurol Phys Ther. 2015 Oct;39(4):241-9. doi: 10.1097/NPT.0000000000000099. |
| 38129896 | Derived | Moslemi Z, Toledo-Aldana EA, Baldwin B, Donkers SJ, Eng JJ, Mondal P, de Zepetnek JOT, Buttigieg J, Levin MC, Mang CS. Task-oriented exercise effects on walking and corticospinal excitability in multiple sclerosis: protocol for a randomized controlled trial. BMC Sports Sci Med Rehabil. 2023 Dec 21;15(1):175. doi: 10.1186/s13102-023-00790-5. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |