Exercise & Brain Health in MS
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|ClinicalTrials.gov Identifier: NCT02263339|
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : June 19, 2019
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:
- 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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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||
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.
- 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 ]
- 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
- 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).
- Changes in Cognition at 12 weeks [ Time Frame: Baseline, Twelve Weeks ]Symbol Digit Modalities Test (SDMT)
- Changes in fatigue at 12 weeks [ Time Frame: Baseline, Twelve Weeks ]Modified Fatigue Impact Scale (MFIS)
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
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Rebecca Spain, MD, MSPH||Oregon Health and Science University|