Exercise Effects in Multiple Sclerosis

NCT ID: NCT05496881

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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

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Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Chronic Progressive Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Exercise Group 1

The intervention will focus on mobility and balance.

Group Type EXPERIMENTAL

Exercise Group 1

Intervention Type OTHER

Prescribed exercises will focus on mobility and balance.

Exercise Group 2

This intervention will focus on physical fitness.

Group Type ACTIVE_COMPARATOR

Exercise Group 2

Intervention Type OTHER

Prescribed exercises will focus on physical fitness.

Exercise Group 3

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

Group Type SHAM_COMPARATOR

Exercise Group 3

Intervention Type OTHER

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

Interventions

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Exercise Group 1

Prescribed exercises will focus on mobility and balance.

Intervention Type OTHER

Exercise Group 2

Prescribed exercises will focus on physical fitness.

Intervention Type OTHER

Exercise Group 3

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Steps Wellness Centre

UNKNOWN

Sponsor Role collaborator

Saskatchewan Health Research Foundation

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role collaborator

University of Regina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cameron Mang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

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University of Regina

Regina, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Cameron Mang, PhD

Role: CONTACT

306-585-4066

Facility Contacts

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Cameron S Mang, PhD

Role: primary

3065854066

G

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21172683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19884575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24174581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32168157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31636661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22740603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21436388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22073939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28206828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17507641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25000308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26247510 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38129896 (View on PubMed)

Other Identifiers

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2021-197

Identifier Type: -

Identifier Source: org_study_id

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