Multiple SclerosisPhase 1NCT05755061
WEBCAMS: Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis
A Phase 1 study testing GEMS Plus and GEMS in people with Multiple Sclerosis and Relapsing-remitting Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial summary
This study is a randomized controlled trial (RCT) that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed (CPS), brain MRI, and other functional outcomes in 32 adults with multiple sclerosis (MS) who are able to walk without an assistive device but… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis
- What is being tested?
- GEMS Plus and GEMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Definite MS diagnosis
- Relapse-free for at least 30 days
- Have Internet access on a device larger than a smartphone
- Willingness and ability to travel to Kessler Foundation 3 times over a 12-month period
- Be insufficiently physically active
- Demonstrate low fall risk based on Activities Specific Balance Confidence scores
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- Demonstrate low contraindications for exercise
- Right handedness
- English as a primary language
- Demonstrate low cognitive processing speed based on a Zoom-administered Symbol Digit Modalities Test
Who cannot join
- Acutely taken corticosteroids within 30 days of enrollment
- Use an assistive device (i.e., cane, crutch, walker, rollator) for ambulation
- Experienced a fall in the past 6 months
- Have uncontrolled major depressive disorder or history of bipolar disorder or schizophrenia
- Regularly taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)
- Demonstrate contraindications for 3T MRI (i.e., having metal/shrapnel in the body, non-MRI compatible aneurysm clips)
- Have severe cognitive impairment causing an inability to follow directions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Aerobic Walking Exercise for Restoring Cognition and Brain in People With Multiple Sclerosis
This study is a randomized controlled trial (RCT) that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed (CPS), brain MRI, and other functional outcomes in 32 adults with multiple sclerosis (MS) who are able to walk without an assistive device but demonstrate slowed CPS. Participants (N=32) will initially undergo screening via telephone, and after satisfying relevant inclusion/exclusion criteria, will provide informed consent, followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. Following this virtual session, participants will come into Kessler Foundation (KF) and complete a 3-hour baseline assessment (T0) that includes a relatively short battery of neuropsychological tests, a 40-minute MRI scan, tests of walking function, a short questionnaire packet, followed by cardiopulmonary exercise testing on a motor-driven treadmill. Following T0, participants will be randomly assigned into one of the two aerobic walking ET programs that are remotely-delivered and supported by KF research assistants. As the conditions are delivered and supported remotely by KF personnel, the exercise itself takes place in the home/community setting. Both conditions involve behavior coaching via Zoom for Healthcare. The experimental condition involves high-frequency, high-intensity aerobic walking ET that exceeds the published guidelines for physical activity for adults with MS (GEMS+). GEMS + initially involves 10 minutes of moderate intensity aerobic walking exercise for 3 days per week and progresses to upwards of 40 minutes of vigorous intensity aerobic walking exercise for 5 days per week by month 12. The comparison condition involves mild-to-moderate aerobic walking exercise training that approximates published guidelines (GEMS). GEMS initially involves 10 minutes of light intensity aerobic walking exercise for 2 days per week and progresses up to 30 minutes of moderate intensity aerobic walking exercise for 3 days per week. Both conditions further will be monitored based on Fitbit-measured steps per exercise session. Of note, the sample size will be enrolled using 2 overlapping waves (Wave 1 = 14 participants, Wave 2 = 18 participants), 3 months apart. Participants will return to KF at the mid-point (i.e., T6) and end-point (i.e., T12) of the 12-month intervention period to complete the same assessments as T0. The T6 and T12 outcomes will be administered by treatment-blinded research assistants.
- Being tested
- GEMS Plus, GEMS
- Keywords
- Exercise, Cognition, Brain, Rehabilitation, Remote
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEMS PlusBehavioural
12-months of home-based walking exercise that occurs 3-5 days per week. The program will progress up to intensities that exceed the published physical activity guidelines for adults with MS
GEMSBehavioural
12-months of home-based walking exercise that occurs 3-5 days per week. The program will progress up to intensities that meet the published physical activity guidelines for adults with MS
| Study group | Role | What they receive |
|---|---|---|
| GEMS Plus | Experimental | Home-based aerobic walking exercise that exceeds published physical activity guidelines for adults with MS Receives: Behavioral: GEMS Plus |
| GEMS | Active comparator | Home-based aerobic walking exercise that meets published physical activity guidelines for adults with MS Receives: Behavioral: GEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive processing speed
Participants will undertake the Symbol Digit Modalities Test as a cognitive test of cognitive processing speed as one of the primary study outcomes
Measured: Baseline; 6-months; 12-months
Change in resting-state functional connectivity
Participants will undertake an fMRI scan to measure resting-state functional connectivity between the thalamus and other brain regions as one of the primary study outcomes
Measured: Baseline; 6-months; 12-months
Secondary outcomes (1)
Change in thalamic volume
Participants will undertake an MRI scan to measure volume of the thalamus as a secondary study outcome
Measured: Baseline; 6-months; 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Feb 2023
- Primary completion28 Feb 2025
- Study completion31 Jan 2027 (estimated)
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.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Sandroff, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755061
- Sponsor's protocol ID
- R-1194-22
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Aerobic Walking Exercise for Restoring Cognition and Brain in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05755061
- Acronym / sponsor ID
- R-1194-22
- Keywords
- Exercise, Cognition, Brain, Rehabilitation, Remote
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- 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.
This study is a randomized controlled trial (RCT) that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed (CPS), brain MRI, and other functional outcomes in 32 adults with multiple sclerosis (MS) who are able to walk without an assistive device but demonstrate slowed CPS. Participants (N=32) will initially undergo screening via telephone, and after satisfying relevant inclusion/exclusion criteria, will provide informed consent, followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. Following this virtual session, participants will come into Kessler Foundation (KF) and complete a 3-hour baseline assessment (T0) that includes a relatively short battery of neuropsychological tests, a 40-minute MRI scan, tests of walking function, a short questionnaire packet, followed by cardiopulmonary exercise testing on a motor-driven treadmill. Following T0, participants will be randomly assigned into one of the two aerobic walking ET programs that are remotely-delivered and supported by KF research assistants. As the conditions are delivered and supported remotely by KF personnel, the exercise itself takes place in the home/community setting. Both conditions involve behavior coaching via Zoom for Healthcare. The experimental condition involves high-frequency, high-intensity aerobic walking ET that exceeds the published guidelines for physical activity for adults with MS (GEMS+). GEMS + initially involves 10 minutes of moderate intensity aerobic walking exercise for 3 days per week and progresses to upwards of 40 minutes of vigorous intensity aerobic walking exercise for 5 days per week by month 12. The comparison condition involves mild-to-moderate aerobic walking exercise training that approximates published guidelines (GEMS). GEMS initially involves 10 minutes of light intensity aerobic walking exercise for 2 days per week and progresses up to 30 minutes of moderate intensity aerobic walking exercise for 3 days per week. Both conditions further will be monitored based on Fitbit-measured steps per exercise session. Of note, the sample size will be enrolled using 2 overlapping waves (Wave 1 = 14 participants, Wave 2 = 18 participants), 3 months apart. Participants will return to KF at the mid-point (i.e., T6) and end-point (i.e., T12) of the 12-month intervention period to complete the same assessments as T0. The T6 and T12 outcomes will be administered by treatment-blinded research assistants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEMS Plus | Experimental | Behavioral: GEMS PlusHome-based aerobic walking exercise that exceeds published physical activity guidelines for adults with MS |
| GEMS | Active comparator | Behavioral: GEMSHome-based aerobic walking exercise that meets published physical activity guidelines for adults with MS |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Definite MS diagnosis
- Relapse-free for at least 30 days
- Have Internet access on a device larger than a smartphone
- Willingness and ability to travel to Kessler Foundation 3 times over a 12-month period
- Be insufficiently physically active
Key exclusion criteria (7 listed)
- Acutely taken corticosteroids within 30 days of enrollment
- Use an assistive device (i.e., cane, crutch, walker, rollator) for ambulation
- Experienced a fall in the past 6 months
- Have uncontrolled major depressive disorder or history of bipolar disorder or schizophrenia
- Regularly taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)
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 |
|---|---|---|
| GEMS Plus12-months of home-based walking exercise that occurs 3-5 days per week. The program will progress up to intensities that exceed the published physical activity guidelines for adults with MS | Behavioural | GEMS Plus |
| GEMS12-months of home-based walking exercise that occurs 3-5 days per week. The program will progress up to intensities that meet the published physical activity guidelines for adults with MS | Behavioural | GEMS |
Primary outcome
Change in cognitive processing speed
Time frame: Baseline; 6-months; 12-months
Participants will undertake the Symbol Digit Modalities Test as a cognitive test of cognitive processing speed as one of the primary study outcomes
Change in resting-state functional connectivity
Time frame: Baseline; 6-months; 12-months
Participants will undertake an fMRI scan to measure resting-state functional connectivity between the thalamus and other brain regions as one of the primary study outcomes
1 secondary outcome
Change in thalamic volume
Time frame: Baseline; 6-months; 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEMS Plus and GEMS in people with Multiple Sclerosis and Relapsing-remitting Multiple Sclerosis, run by Kessler Foundation 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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in cognitive processing speed (time frame: Baseline; 6-months; 12-months). The study lists 2 primary outcomes in all. 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 6 Aug 2026.