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Study of Exercise on Impact of Cognitive Functioning in Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT02106052
Recruitment Status : Recruiting
First Posted : April 7, 2014
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Charles Bombardier, University of Washington

Brief Summary:

Cognitive impairment affects roughly 50% of people with multiple sclerosis (MS). There are currently no satisfactory medical treatments for cognitive impairments related to MS and alternative forms of treatment are needed. Exercise training can improve cognition in older adults and people with mild cognitive impairments, including those with early Alzheimer's disease. Therefore, the investigators plan to conduct the first definitive study that will test the theory that moderately intense aerobic exercise can improve cognition in people with MS-related impairment - specifically in information processing speed - more so than non-aerobic stretching and toning (both forms of exercise will be performed 3 days per week for 6 months).

Primary study hypothesis: The investigators hypothesize greater improvement in speed of information processing from pre- to post-treatment in the aerobic exercise group compared to the stretching and toning group (attention control).

Secondary study hypothesis: The investigators hypothesize greater improvement in other cognitive domains and patient reported outcomes from pre- to post-testing in the aerobic exercise group compared to the stretching and toning group (attention control).

The investigators plan to recruit 125 adults with MS who can walk without assistance and without rest for at least 100 meters and have mild weaknesses in information processing speed. The investigators will randomly assign 50% of participants to an aerobic exercise program and 50% to a non-aerobic exercise program (stretching and toning). In order to determine whether the intervention is successful, the investigators will compare cognitive functioning in both exercise groups before the exercise-training program, at the end of the 6-month training program and three months after the end of the training program. If our study findings support our hypotheses, this would be a relatively no-barriers treatment option to further explore for other people with MS including people with greater and lesser baseline disability.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Aerobic exercise Other: Stretching and toning exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Aerobic Exercise on Cognition in Multiple Sclerosis (MS Exercise Study)
Study Start Date : March 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aerobic exercise Other: Aerobic exercise
The aerobic exercise condition is a graduated program of supervised aerobic exercise up to one hour per day, three days per week, and lasting 6 months. The structured exercise portion of the sessions will initially last for 15-20 minutes at 40-50% heart rate reserve (HRR) and progressively increase up to 35-40 minutes in duration at 65-75% HRR during the last month of the program. The program will focus on large, dynamic movements of the lower extremities (e.g. leg cycling ergometry). There may be some individual variation in adaptations that dictate the exact characteristics of the program.

Stretching and toning exercise Other: Stretching and toning exercise
The stretching and toning condition is a supervised stretching program with Therabands up to one hour per day, three days per week, and lasting 6 months. The stretching exercises will be based on a manual published by the National Multiple Sclerosis Society (NMSS) that has been standardized, manualized for reproducibility, and the investigators will progressively include more exercises and sets with Therabands for resistance over the course of the 6-month period.




Primary Outcome Measures :
  1. Composite score of the Paced Auditory Serial Addition Test-3 (PASAT-3") and the oral version of the Symbol-Digit Modalities Test (SDMT) [ Time Frame: Baseline and six months after baseline. ]
    The PASAT-3" is an auditory processing speed measure in which patients are exposed to single digit numbers voiced every three seconds. After each number presentation, the patient's task is to respond with the sum of the last two digits presented. There are 60 stimuli. The main score is the number of correct responses. The SDMT will be used to measure visual processing speed. This test presents a stimulus key of numbers paired with abstract symbols at the top of a page. Patients scan the page below the key that has rows of symbols without the paired numbers. The task is to generate the associated numbers orally as fast as possible.


Secondary Outcome Measures :
  1. Delis Kaplan Executive Function System Sorting Test (DKEFS) [ Time Frame: The DKEFS will be administered at six months after baseline. ]
    The DKEFS will be used to assess higher executive function. Six cards are presented which can be sorted in at least eight different ways (e.g., card color, card shape, semantic association). Patients are allowed four minutes with each deck to sort the cards in as many ways possible. The dependent variables are the total number of correct sorts and the total verbal description score among the two decks.

  2. California Verbal Learning Test, second edition (CVLT2) [ Time Frame: The CVLT2 will be administered at six months after baseline. ]
    The CVLT2 will be used to evaluate multi-trial learning and long-term recall for verbal information. The test presents a list of 16 words over 5 learning trials using a selective reminding procedure. Patients are asked to recall as many words as they can after each trial followed by a delay interval, after which they are again asked to recall as many words from the list as possible. The investigators will use the total number of words recalled during the initial learning trials and the number of words recalled after the delay interval as outcomes for this study.

  3. Brief Visuospatial Memory Test Revised (BVMTR) [ Time Frame: The BVMTR will be administered at six months after baseline. ]
    The BVMTR will be used to assess visuospatial memory. The test presents a matrix of six visual designs over three learning trials, each time for 10 seconds. After each trial the patient is asked to reproduce the figures in their correct location. After a 20-25 minute delay, patients are again asked to redraw the designs. The investigators will use the total score over the three learning trials and the total number recalled after the 20-25 minute delay as outcomes.

  4. The Controlled Oral Word Association Test (COWAT) [ Time Frame: The COWAT will be administered at six months after baseline. ]
    The COWAT will be used to assess verbal fluency. The test requires patients to generate words orally that begin with a given letter of the alphabet. The outcome is the total number of correct words over the three trials.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English as primary language.
  • At least 9th grade education.
  • Physician confirmed, clinically definite MS diagnosis as defined by the revised McDonald criteria.
  • All MS subtypes will be included.
  • MS diagnosis at least 6 months prior.
  • Impaired speed of information processing and working memory based on either the PASAT-3" or the SDMT (i.e. z <-1.5 controlling for age, education and sex).
  • Physician clearance to engage in aerobic exercise training.
  • Able to walk at least 100 meters without assistance (Expanded Disability Severity Scale score equivalent 0-5.5).
  • Currently exercising less than public health recommendations (engaging in less than 30 minutes of structured physical activity less than 3 times per week during the past 6 months).
  • Willingness not to undertake additional structured exercise or leisure time physical activity during the 6-month trial.
  • Willing and able to participate in either exercise training program 3 days per week for 6 months at a YMCA in the Greater Seattle Area.

Exclusion Criteria:

  • Near visual acuity with correction 20/70 or worse.
  • Contra-indications for exercise training based on American Heart Association (AHA)/ACSM screening criteria using PAR-Q.
  • Using any medication known to have adverse effects on motor or cognitive function, including monoamine oxidase inhibitors, sympathomimetics, antipsychotic agents, modafinil, oxybutynin, tricyclic antidepressants, cholinesterase inhibitors and anticonvulsants other than gabapentin and pregabalin. The following are permitted if the patient has been on a stable dose for at least 6 weeks: short acting benzodiazepines (qhs administration only), anti-spasmodics, selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors.
  • Received steroids in last 30 days.
  • Relapse in the last 90 days.
  • Undergone neuropsychological testing within the past 6-months.
  • Neurological/psychological disease other than MS that may impact cognitive status, e.g. Alzheimer's disease, Parkinson's, stroke, TIA, Vascular Dementia, Huntington's, traumatic brain injury or chronic CNS infection.
  • Dementia based on a definition validated in people with MS using the MACFIMS (> 2 SD below the mean on at least one memory test and > 2 SD below the mean on at least one neuropsychological test in another domain).
  • Prior history of diagnosis or treatment for serious mental illness (obsessive-compulsive disorder, schizophrenia, other psychotic disorders, bipolar disorder).
  • Diagnosis of major depressive disorder prior to the diagnosis of MS.
  • History of significant developmental or learning disorder that may affect participation and confound interpretation of study results.
  • Current major depressive disorder.
  • Current alcohol or other drug abuse as measured by the WHO Alcohol, Smoking and Substance Involvement Screening Test (WHO ASSIST V3.0).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106052


Contacts
Contact: Katharine S Alexander, BA 206-221-5642 ksa3@uw.edu
Contact: Cathea M Carey, BS 206-897-1677 cmc37@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Cathea M Carey, BS    206-897-1677    cmc37@uw.edu   
Principal Investigator: Charles H Bombardier, PhD         
Sponsors and Collaborators
University of Washington
National Multiple Sclerosis Society
Investigators
Principal Investigator: Charles H Bombardier, PhD University of Washington

Responsible Party: Charles Bombardier, Professor, Department of Rehabilitation Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02106052     History of Changes
Other Study ID Numbers: STUDY00003682
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Keywords provided by Charles Bombardier, University of Washington:
cognitive function
cognitive impairment
cognitive intervention
cognitive improvement
information processing speed
exercise training program
aerobic exercise
stretching and toning
Multiple sclerosis
executive function

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases