Exercise Effects in Multiple Sclerosis

NCT05496881 | Unknown

• 1 other identifier: 2021-197
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Motor Evoked Potential Amplitude

  6 weeks post intervention

Other Outcomes (10)

• Mini Balance Evaluation Systems Test

  6 weeks post intervention

• Multiple Sclerosis Impact Scale

  6 weeks post intervention

• 9-Hole Pegboard Test

  6 weeks post intervention

Study Arms (3)

Exercise Group 1

EXPERIMENTAL

The intervention will focus on mobility and balance.

Other: Exercise Group 1

Exercise Group 2

ACTIVE COMPARATOR

This intervention will focus on physical fitness.

Other: Exercise Group 2

Exercise Group 3

SHAM COMPARATOR

This intervention will focus on flexibility, range of motion, and muscle tone.

Other: Exercise Group 3

Interventions

Exercise Group 1 OTHER

Prescribed exercises will focus on mobility and balance.

Exercise Group 1

Exercise Group 2 OTHER

Prescribed exercises will focus on physical fitness.

Exercise Group 2

Exercise Group 3 OTHER

Prescribed exercises will focus on flexibility, range of motion, and muscle tone.

Exercise Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead
• First Steps Wellness Centre: collaborator
• Saskatchewan Health Research Foundation: collaborator
• University of Saskatchewan: collaborator

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S5N6, Canada

RECRUITING

Related Publications (13)

• 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.

  PMID: 21172683 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.

  PMID: 19884575 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.

  PMID: 24174581 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.

  PMID: 32168157 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.

  PMID: 31636661 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.

  PMID: 22740603 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.

  PMID: 21436388 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.

  PMID: 22073939 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.

  PMID: 28206828 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.

  PMID: 17507641 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.

  PMID: 25000308 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.

  PMID: 26247510 BACKGROUND

• 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.

  PMID: 38129896 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Mobility Limitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Cameron Mang, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cameron Mang, PhD

CONTACT

306-585-4066; cameron.mang@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: August 11, 2022
• Study Start: June 15, 2022
• Primary Completion: October 31, 2024
• Study Completion: April 30, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)