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Exercise & Brain Health in MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02263339
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Rebecca Spain, Oregon Health and Science University

Brief Summary:

The purpose of this study is to learn more about multiple sclerosis (MS). The investigators are studying whether aerobic exercise is better than a stretching program at improving brain health in people with MS. We want to learn:

  1. If it is safe and practical for people with MS to participate in an aerobic exercise program with the goal of increasing cardiac fitness. Cardiac fitness is measured with exercise stress tests at the beginning and end of the study.
  2. If aerobic exercise improves brain metabolism, a reflection of brain health, more than stretching. Brain metabolism is measured by MRIs at the beginning and end of the study.

There is a 50% chance of being in the aerobic exercise or the stretching program.

There are between 8 and 36 visits to OHSU, depending on the intervention group. The total duration of the study is at most 21 weeks.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Aerobic Exercise Behavioral: Stretching Behavioral: Aerobic Exercise- Healthy Subjects Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Exercise to Improve Brain Metabolism in MS
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise Behavioral: Aerobic Exercise
Each subject will exercise 30 minutes per session, four times per week for 8 weeks at the OHSU Human Performance Laboratory (HPL). Choice of treadmill or cycle ergometer for each subject will be made based on subject ability by the HPL staff and maintained for the duration of the study. Exercise intensity will be determined by training heart rate to be provided to the subject based on the anaerobic threshold during initial stress test. Throughout the study, patients will be instructed not to alter their diet or baseline level of activity.

Active Comparator: Stretching Program Behavioral: Stretching
Each subject will follow a self-guided stretching program 30 minutes per session, four times per week for 8 weeks. The initial session will be supervised at the OHSU Human Performance Laboratory (HPL) and additional supervised sessions will occur every 2 weeks to support compliance with the program. Throughout the study patients will be instructed not to alter their diet or baseline level of activity.

Active Comparator: Aerobic Exercise, Healthy Subjects Behavioral: Aerobic Exercise- Healthy Subjects
Each subject will follow a self-guided aerobic exercise program 30 minutes per session, four times per week for 8 weeks. The initial session will be supervised at the OHSU Human Performance Laboratory (HPL) and additional supervised sessions will occur every 2 weeks to support compliance with the program. Throughout the study patients will be instructed not to alter their diet or baseline level of activity.




Primary Outcome Measures :
  1. Comparison of correlations in changes in VO2Max at 12 weeks with changes in brain ATP production at 12 weeks between aerobic exercise group and stretching group. [ Time Frame: Baseline, Twelve Weeks ]
    1. Changes in VO2Max testing consists of an aerobic exercise test on a treadmill or stationary bicycle to measure blood pressure, heart rate, and oxygen consumption, and lung function tests
    2. Brain ATP production is measured using a 31P MRSI imaging procedure: MRI data is collected using 7 tesla MRI instrument. All MRI data will be collected within 1.25 hour on each session (2.5 hour total/subject).


Secondary Outcome Measures :
  1. Changes in Cognition at 12 weeks [ Time Frame: Baseline, Twelve Weeks ]
    Symbol Digit Modalities Test (SDMT)

  2. Changes in fatigue at 12 weeks [ Time Frame: Baseline, Twelve Weeks ]
    Modified Fatigue Impact Scale (MFIS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i. Physician-confirmed diagnosis of relapsing-remitting MS ii. > 18 years old iii. Expanded Disability Status Scale (EDSS) < 4.0 iv. Able to give informed consent

Exclusion Criteria:

i. Current cardiopulmonary disease requiring treatment (hypertension permitted) ii. Medical or biophysical conditions that do not permit use of either a cycle ergometer or treadmill iii. MRI contraindications (pacemaker, wires, defibrillator, or implanted heart valves, head surgery requiring aneurysm clips, or any type of electric device (stimulator or pump) implanted in the body) iv. MS exacerbation in the last 30 days v. Pregnant women: Pregnancy status determined by menstrual history and contraceptive method. Confirmatory urine pregnancy test will be used if pregnancy status is uncertain


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): NCT02263339


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Rebecca Spain, MD, MSPH Oregon Health and Science University

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Responsible Party: Rebecca Spain, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02263339    
Other Study ID Numbers: IRB 10599
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by Rebecca Spain, Oregon Health and Science University:
Exercise
MRI
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases