Exercise Effects in Multiple Sclerosis

University of Regina

Status: Enrolling

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Chronic Progressive

Treatments: Other: Exercise Group 3; Other: Exercise Group 2; Other: Exercise Group 1

Study type: Interventional

Funder types: Other

Identifiers

NCT05496881

2021-197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 3 patient groups

Exercise Group 1

Experimental group

Description:

The intervention will focus on mobility and balance.

Treatment:

Other: Exercise Group 1

Exercise Group 2

Active Comparator group

Description:

This intervention will focus on physical fitness.

Treatment:

Other: Exercise Group 2

Exercise Group 3

Sham Comparator group

Description:

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

Treatment:

Other: Exercise Group 3