Exercise Training for Cognitive Impairment in Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

Overseen byBrian M Sandroff, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Kessler Foundation

No Placebo Group

Trial Summary

What is the purpose of this trial?

Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and American College of Sports Medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional MRI outcomes in 88 cognitively-impaired persons with MS. This study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common MS-related cognitive impairment) and improving brain health in persons with MS.

Eligibility Criteria

This trial is for people aged 18-65 with a definite MS diagnosis, an EDSS score of 0-4.0, and slowed cognitive processing speed. Participants must be relapse-free for at least 30 days, right-handed, have decent vision and mental state scores, stable on MS therapy for six months, and not have MRI contraindications.

Inclusion Criteria

I am not currently in cognitive rehabilitation or doing regular brain exercises.

I am between 18 and 65 years old.

I haven't taken corticosteroids or had a relapse in the last 30 days.

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Treatment Details

Interventions

Stretching-and-Toning Exercise Training (Behavioural Intervention)
Treadmill Walking Exercise Training (Behavioural Intervention)

Trial OverviewThe study compares the effects of a supervised treadmill walking exercise program against stretching-and-toning exercises on cognitive speed and brain function in those with MS-related cognitive impairments over three months.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Treadmill Walking Exercise TrainingExperimental Treatment1 Intervention

This condition will include 3-months of supervised, progressive light, moderate, and vigorous intensity treadmill walking exercise training based on ACSM guidelines for maximizing adaptations with exercise training. Exercise intensities will be prescribed based on percent oxygen consumption reserve (% VO2R) using values derived from the baseline graded exercise test. The exercise training itself will be led by trained exercise leaders who are not involved in the collection of outcome assessments. At the outset of each session, participants will be fitted with a Polar HR Monitor (Oy, Finland), and HR will be monitored continuously throughout each session. Each session will begin with a 5-10 min warm-up, followed by the exercise; the target heart rate reserve (HRR) range associated with the VO2R range will be maintained for as long as possible during each exercise period. This will be followed by a 5-10 min cool-down.

Group II: Stretching-and-Toning Exercise TrainingActive Control1 Intervention

The active, non-aerobic exercise condition will involve stretching-and-toning activities using the same frequency and duration of the treadmill walking exercise condition. These activities will be based on a manual provided by the National Multiple Sclerosis Society and sessions will be led by trained exercise leaders who are not involved in the collection of outcome assessments. Activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot. The progression of activities over the 3-month period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands that provide minimal resistance. Each session is designed to last up to 60 minutes in total. Each session will begin with a warm-up of up to 10 minutes, followed by stretching-and-toning (following the same duration as the treadmill walking exercise training condition) activities, and a cool-down of up to 10 minutes.