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Clinical Trials/NCT05496881
NCT05496881
Recruiting
Not Applicable

Evaluating Task-Oriented Exercise Effects on Walking Function and the Central Nervous System in People With Multiple Sclerosis

University of Regina1 site in 1 country69 target enrollmentJune 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis, Primary Progressive
Sponsor
University of Regina
Enrollment
69
Locations
1
Primary Endpoint
Timed 25-Foot Walk Test
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
April 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Motor Evoked Potential Amplitude(6 weeks post intervention)

Study Sites (1)

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