Multiple Sclerosis, Primary ProgressiveNCT05496881
Exercise Effects in Multiple Sclerosis
A study testing Exercise Group 1, Exercise Group 2 and Exercise Group 3 in people with Multiple Sclerosis, Primary Progressive and Multiple Sclerosis, Relapsing-Remitting, run by University of Regina at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
- What is being tested?
- Exercise Group 1, Exercise Group 2 and Exercise Group 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2022to 30 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of progressive MS by a neurologist
- physician clearance for exercise
- a Patient-Determined Disease Steps (PDSS) score between 3 and 7 (i.e., moderate motor disability)
- a Timed 25-Foot Walk (T25-FW) test time > 6.0 s.
Who cannot join
- a baseline score >24 on the Godin-Shephard Leisure Time Physical Activity Questionnaire (i.e., high physical activity levels)
- absolute contraindications to TMS (e.g. history of seizure)
- a history of any neurological conditions other than MS
- relapse in the past three months (self-reported, neurologist confirmed)
- psychiatric diagnosis
- substance abuse
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S5N6
Cameron S Mang, PhD, 3065854066, cameron.mang@uregina.ca
G
About this study
Official title: Evaluating Task-Oriented Exercise Effects on Walking Function and the Central Nervous System in People With Multiple Sclerosis
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
- Being tested
- Exercise Group 1, Exercise Group 2, Exercise Group 3
- Keywords
- Progressive Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Central Nervous System, Motor Learning, Transcranial Magnetic Stimulation, Mobility Limitation
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Group 1Other
Prescribed exercises will focus on mobility and balance.
Exercise Group 2Other
Prescribed exercises will focus on physical fitness.
Exercise Group 3Other
Prescribed exercises will focus on flexibility, range of motion, and muscle tone.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group 1 | Experimental | The intervention will focus on mobility and balance. Receives: Other: Exercise Group 1 |
| Exercise Group 2 | Active comparator | This intervention will focus on physical fitness. Receives: Other: Exercise Group 2 |
| Exercise Group 3 | Sham comparator | This intervention will focus on flexibility, range of motion, and muscle tone. Receives: Other: Exercise Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post intervention
Secondary outcomes (1)
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.
Measured: 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start15 Jun 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Primary ProgressiveStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- First Steps Wellness Centre, Saskatchewan Health Research Foundation, University of Saskatchewan
- Responsible party
- Sponsor
- Investigators
- Cameron Mang, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496881
- Sponsor's protocol ID
- 2021-197
- Status last verified
- Jan 2024
- First submitted
- 14 Apr 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers.
Publications
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.
PubMed 21172683Dalgas 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.
PubMed 19884575Goldman 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.
PubMed 24174581Chaves 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.
PubMed 32168157Snow 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.
PubMed 31636661Kieseier 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.
PubMed 22740603Phan-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.
PubMed 21436388Coleman 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.
PubMed 22073939Motl 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.
PubMed 28206828Yen 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.
PubMed 17507641Guerra 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.
PubMed 25000308Pilutti 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.
PubMed 26247510Moslemi 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.
PubMed 38129896
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Task-Oriented Exercise Effects on Walking Function and the Central Nervous System in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05496881
- Acronym / sponsor ID
- 2021-197
- Conditions
- Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
- Keywords
- Progressive Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Central Nervous System, Motor Learning, Transcranial Magnetic Stimulation, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- First Steps Wellness Centre, Saskatchewan Health Research Foundation, University of Saskatchewan
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 11 Aug 2022 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group 1 | Experimental | Other: Exercise Group 1The intervention will focus on mobility and balance. |
| Exercise Group 2 | Active comparator | Other: Exercise Group 2This intervention will focus on physical fitness. |
| Exercise Group 3 | Sham comparator | Other: Exercise Group 3This intervention will focus on flexibility, range of motion, and muscle tone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of progressive MS by a neurologist
- physician clearance for exercise
- a Patient-Determined Disease Steps (PDSS) score between 3 and 7 (i.e., moderate motor disability)
- a Timed 25-Foot Walk (T25-FW) test time > 6.0 s.
Key exclusion criteria (6 listed)
- a baseline score >24 on the Godin-Shephard Leisure Time Physical Activity Questionnaire (i.e., high physical activity levels)
- absolute contraindications to TMS (e.g. history of seizure)
- a history of any neurological conditions other than MS
- relapse in the past three months (self-reported, neurologist confirmed)
- psychiatric diagnosis
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 |
|---|---|---|
| Exercise Group 1Prescribed exercises will focus on mobility and balance. | Other | Exercise Group 1 |
| Exercise Group 2Prescribed exercises will focus on physical fitness. | Other | Exercise Group 2 |
| Exercise Group 3Prescribed exercises will focus on flexibility, range of motion, and muscle tone. | Other | Exercise Group 3 |
Primary outcome
Timed 25-Foot Walk Test
Time frame: 6 weeks post intervention
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.
1 secondary outcome
Motor Evoked Potential Amplitude
Time frame: 6 weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 21172683Warraich 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.
- Background: PubMed 19884575Dalgas 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.
- Background: PubMed 24174581Goldman 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.
- Background: PubMed 32168157Chaves 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.
- Background: PubMed 31636661Snow 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.
- Background: PubMed 22740603Kieseier 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.
- Background: PubMed 21436388Phan-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.
- Background: PubMed 22073939Coleman 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.
- Background: PubMed 28206828Motl 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.
- Background: PubMed 17507641Yen 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.
- Background: PubMed 25000308Guerra 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.
- Background: PubMed 26247510Pilutti 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers.
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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.
Cameron Mang, PhD principal investigator
University of Regina
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 Group 1, Exercise Group 2 and Exercise Group 3 in people with Multiple Sclerosis, Primary Progressive and Multiple Sclerosis, Relapsing-Remitting, run by University of Regina at 1 site in Canada.
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 4 inclusion and 6 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 15 Feb 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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 Cameron Mang, PhD (306-585-4066, cameron.mang@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25-Foot Walk Test (time frame: 6 weeks post intervention). 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 NCT05496881, which also lists 13 linked publications.
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 15 Feb 2024.