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Exercise Training for Cognitive Impairment in Multiple Sclerosis

N/A

Waitlist Available

Led By Brian M Sandroff, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must not be actively engaging in cognitive rehabilitation, or participating in regular brain fitness activities

Participants must be between the ages of 18-65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks

Awards & highlights

Study Summary

This trial will test if treadmill walking can help improve cognitive processing speed for people with MS.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

While specific side effects are not listed for this type of physical intervention study, participants may experience general exercise-related discomforts such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 65 years old.

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

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I have never been diagnosed with major depression, schizophrenia, bipolar disorder, or substance-abuse disorders.

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I am not taking any medications that can affect my thinking.

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I can walk without assistance, based on my EDSS score.

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My mental state is clear enough for decision making.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cognitive Processing Speed

Thalamocortical Resting State Functional Connectivity Region 2

Thalamocortical Resting-State Functional Connectivity Region 1

Trial Design

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.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Kessler FoundationLead Sponsor

173 Previous Clinical Trials

10,665 Total Patients Enrolled

32 Trials studying Multiple Sclerosis

1,574 Patients Enrolled for Multiple Sclerosis

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,698 Total Patients Enrolled

18 Trials studying Multiple Sclerosis

1,765 Patients Enrolled for Multiple Sclerosis

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,536 Total Patients Enrolled

9 Trials studying Multiple Sclerosis

1,277 Patients Enrolled for Multiple Sclerosis

Media Library

Treadmill Walking Exercise Training Clinical Trial Eligibility Overview. Trial Name: NCT03677440 — N/A

Multiple Sclerosis Research Study Groups: Stretching-and-Toning Exercise Training, Treadmill Walking Exercise Training

Multiple Sclerosis Clinical Trial 2023: Treadmill Walking Exercise Training Highlights & Side Effects. Trial Name: NCT03677440 — N/A

Treadmill Walking Exercise Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03677440 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over thirty eligible to partake in this clinical investigation?

"This research is open to all individuals who are of legal age and younger than 65 years old."

Answered by AI

Is there any chance I can become part of this clinical trial?

"This clinical trial is seeking 88 people with multiple sclerosis who meet the following conditions: ambulatory, slowed cognitive processing speed (CPS), aged between 18-65, have a definitive MS diagnosis, no recent history of relapse and corticosteroids use within 30 days, absence of major depressive disorder or substance abuse disorders, right-handedness and visual acuity better than 20/80; but individuals with diagnosed cardiovascular metabolic or renal disease may be included if approved by their physician."

Answered by AI

What is the uppermost limit on enrolment for this clinical trial?

"Affirmative. According to the records available on clinicaltrials.gov, this medical experiment is currently in recruitment mode. It was initially posted on February 5th 2019 and has since been updated most recently on October 4th 2021. There is a need for 88 participants from one distinct site."

Answered by AI

Are there any slots open for volunteers in this experiment?

"Affirmative, according to clinicaltrials.gov the trial that was posted on February 5th 2019 is still recruiting patients. Updates were made as recently as October 4th 2021 and 88 study participants are required from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT

Brian Sandroff 2019. "Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03677440.

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