Multiple Sclerosis Clinical Trial
Official title:
Aerobic Exercise to Improve Brain Metabolism in MS
NCT number | NCT02263339 |
Other study ID # | IRB 10599 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | May 25, 2016 |
Verified date | June 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 25, 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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). |
Baseline, Twelve Weeks | |
Secondary | Changes in Cognition at 12 weeks | Symbol Digit Modalities Test (SDMT) | Baseline, Twelve Weeks | |
Secondary | Changes in fatigue at 12 weeks | Modified Fatigue Impact Scale (MFIS) | Baseline, Twelve Weeks |
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