Multiple SclerosisNCT02263339
Exercise & Brain Health in MS
A study testing Aerobic Exercise, Stretching and Aerobic Exercise- Healthy Subjects in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Aerobic Exercise, Stretching and Aerobic Exercise- Healthy Subjects
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 25 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Aerobic Exercise to Improve Brain Metabolism in MS
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.
Read more
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.
Read the detailed description
Multiple sclerosis (MS) is a disease of brain, spinal cord and optic nerves. Current MS therapies reduce the frequency and severity of MS flare-ups, but do not help MS in later stages of disease characterized by slow progression of disability. One obstacle to developing therapies for progressive aspects of disease is a lack of ability to measure progression and brain repair.
A new MRI technique developed by Bill Rooney, PhD, (co-investigator, OHSU Advanced Imaging Resource Center) looks at brain health by measuring levels of phosphorous. Phosphorous levels are thought to reflect energy stores produced by brain cells. The healthier the brain, the greater the energy stores seen as higher the levels of phosphorous on imaging. Dr. Rooney has shown decreased levels of phosphorous on brain MRIs from people with MS. We propose that therapies that boost brain cell health will lead to an increase in brain cell energy stores and be reflected by an increase in phosphorous levels on MRI spectroscopy.
In order to test whether improvements in brain energy stores can be seen as increased phosphorous levels, we will use a therapy known to improve energy stores in muscles and see if it also does so in the brain. We measure how much aerobic exercise increases energy stores in muscles by measuring oxygen utilization during an exercise stress test. Therefore in this study, we will see if the aerobic exercise that improves muscle energy stores (seen as an increase in oxygen utilization) corresponds to an increase in brain energy stores (seen as an increase in phosphorous levels).
Specific Aim 1. To determine if it is safe and feasible to conduct an aerobic exercise intervention in MS patients to achieve an increase in oxygen utilization by 5-15%.
Hypothesis: An MS cohort undergoing a structured aerobic exercise program will increase their aerobic capacity by 5-15% as measured by oxygen utilization testing and not experience adverse events related to the exercise program.
Specific Aim 2. To determine if brain phosphorous levels by MR spectroscopy before and after an aerobic exercise intervention increases in association with increases in oxygen utilization.
Hypothesis: Aerobic exercise will increase energy stores in both muscles and the brain. Body energy stores will be measured by oxygen utilization testing and brain energy stores by phosphorous levels. We expect that increases in by oxygen utilization after a structured exercise program will be associated with increases in phosphorous levels. We do not expect increases in either by oxygen utilization or phosphorous levels in an MS cohort matched for sex and baseline aerobic capacity that participates in a non-aerobic stretching program of the same duration and intensity.
Outcome measures: The primary outcome is change in brain phosphorous levels by MRI spectroscopy. The secondary outcomes are changes in oxygen utilization levels, walking and balance tests, and changes in cognitive function and energy levels.
Methods: Participants will be enrolled over a 1 year period. Potential subjects will undergo a baseline exercise stress test for oxygen utilization. Participants matched by sex and baseline oxygen utilization level will undergo a baseline MRI spectroscopy study and then be randomly assigned to either an aerobic exercise program or a self-guided stretching program. The aerobic exercise program consists of supervised 30 minute sessions of either treadmill or stationary bicycle exercise, 4 days per week for 8 weeks. The self-guided home stretching program consists of 30 minute sessions, 4 days a week for 8 weeks with supervised sessions occurring every 2 weeks. All participants will undergo a final exercise stress test and MRI spectroscopy. Only participants who are matched and assigned to either exercise or stretching groups will undergo MRI testing and receive payment for participation.
- Conditions
- Multiple Sclerosis
- Being tested
- Aerobic Exercise, Stretching, Aerobic Exercise- Healthy Subjects
- Keywords
- Exercise, MRI
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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.
StretchingBehavioural
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.
Aerobic Exercise- Healthy SubjectsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Not described Receives: Behavioral: Aerobic Exercise |
| Stretching Program | Active comparator | Not described Receives: Behavioral: Stretching |
| Aerobic Exercise, Healthy Subjects | Active comparator | Not described Receives: Behavioral: Aerobic Exercise- Healthy Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Twelve Weeks
Secondary outcomes (2)
Changes in Cognition at 12 weeks
Symbol Digit Modalities Test (SDMT)
Measured: Baseline, Twelve Weeks
Changes in fatigue at 12 weeks
Modified Fatigue Impact Scale (MFIS)
Measured: Baseline, Twelve Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Spain, Oregon Health and Science University
- Investigators
- Rebecca Spain, MD, MSPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263339
- Sponsor's protocol ID
- IRB 10599
- Status last verified
- Jun 2019
- First submitted
- 2 Oct 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise to Improve Brain Metabolism in MS
- ClinicalTrials.gov ID
- NCT02263339
- Acronym / sponsor ID
- IRB 10599
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple sclerosis (MS) is a disease of brain, spinal cord and optic nerves. Current MS therapies reduce the frequency and severity of MS flare-ups, but do not help MS in later stages of disease characterized by slow progression of disability. One obstacle to developing therapies for progressive aspects of disease is a lack of ability to measure progression and brain repair.
A new MRI technique developed by Bill Rooney, PhD, (co-investigator, OHSU Advanced Imaging Resource Center) looks at brain health by measuring levels of phosphorous. Phosphorous levels are thought to reflect energy stores produced by brain cells. The healthier the brain, the greater the energy stores seen as higher the levels of phosphorous on imaging. Dr. Rooney has shown decreased levels of phosphorous on brain MRIs from people with MS. We propose that therapies that boost brain cell health will lead to an increase in brain cell energy stores and be reflected by an increase in phosphorous levels on MRI spectroscopy.
In order to test whether improvements in brain energy stores can be seen as increased phosphorous levels, we will use a therapy known to improve energy stores in muscles and see if it also does so in the brain. We measure how much aerobic exercise increases energy stores in muscles by measuring oxygen utilization during an exercise stress test. Therefore in this study, we will see if the aerobic exercise that improves muscle energy stores (seen as an increase in oxygen utilization) corresponds to an increase in brain energy stores (seen as an increase in phosphorous levels).
Specific Aim 1. To determine if it is safe and feasible to conduct an aerobic exercise intervention in MS patients to achieve an increase in oxygen utilization by 5-15%.
Hypothesis: An MS cohort undergoing a structured aerobic exercise program will increase their aerobic capacity by 5-15% as measured by oxygen utilization testing and not experience adverse events related to the exercise program.
Specific Aim 2. To determine if brain phosphorous levels by MR spectroscopy before and after an aerobic exercise intervention increases in association with increases in oxygen utilization.
Hypothesis: Aerobic exercise will increase energy stores in both muscles and the brain. Body energy stores will be measured by oxygen utilization testing and brain energy stores by phosphorous levels. We expect that increases in by oxygen utilization after a structured exercise program will be associated with increases in phosphorous levels. We do not expect increases in either by oxygen utilization or phosphorous levels in an MS cohort matched for sex and baseline aerobic capacity that participates in a non-aerobic stretching program of the same duration and intensity.
Outcome measures: The primary outcome is change in brain phosphorous levels by MRI spectroscopy. The secondary outcomes are changes in oxygen utilization levels, walking and balance tests, and changes in cognitive function and energy levels.
Methods: Participants will be enrolled over a 1 year period. Potential subjects will undergo a baseline exercise stress test for oxygen utilization. Participants matched by sex and baseline oxygen utilization level will undergo a baseline MRI spectroscopy study and then be randomly assigned to either an aerobic exercise program or a self-guided stretching program. The aerobic exercise program consists of supervised 30 minute sessions of either treadmill or stationary bicycle exercise, 4 days per week for 8 weeks. The self-guided home stretching program consists of 30 minute sessions, 4 days a week for 8 weeks with supervised sessions occurring every 2 weeks. All participants will undergo a final exercise stress test and MRI spectroscopy. Only participants who are matched and assigned to either exercise or stretching groups will undergo MRI testing and receive payment for participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise |
| Stretching Program | Active comparator | Behavioral: Stretching |
| Aerobic Exercise, Healthy Subjects | Active comparator | Behavioral: Aerobic Exercise- Healthy Subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseEach 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. | Behavioural | Aerobic Exercise |
| StretchingEach 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. | Behavioural | Stretching Program |
| Aerobic Exercise- Healthy SubjectsEach 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. | Behavioural | Aerobic Exercise, Healthy Subjects |
Primary outcome
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).
2 secondary outcomes
Changes in Cognition at 12 weeks
Time frame: Baseline, Twelve Weeks
Changes in fatigue at 12 weeks
Time frame: Baseline, Twelve Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Spain, MD, MSPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Stretching and Aerobic Exercise- Healthy Subjects in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.