Multiple SclerosisEarly Phase 1REACT-MSNCT05344040
Remote Exercise Effects on Cognitive Processing Speed in Multiple Sclerosis: A Pilot Trial
A Early Phase 1 study testing Remotely Delivered and Supported Aerobic Walking Exercise Training and Remotely Delivered and Supported Stretching and Toning Exercise Training in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial summary
Cognitive processing speed (CPS) impairment is prevalent, impactful, and poorly-managed in multiple sclerosis (MS). Upwards of 67% of patients present with MS-related CPS impairment, which is associated with poor everyday life outcomes. There are no FDA-approved pharmacological treatments for CPS impairment in MS. 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?
- Remotely Delivered and Supported Aerobic Walking Exercise Training and Remotely Delivered and Supported Stretching and Toning Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 1 Dec 2022
- Phase
- Early Phase 1
- 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
- MS Diagnosis: All participants must have a definite diagnosis of MS.
- Most recent exacerbation: MS subjects will be free from exacerbations and not have acutely taken corticosteroids at least 30 days prior to enrollment.
- Internet and email access: All participants must have Internet access on a device larger than a smartphone (i.e., full-size iPad, desktop, laptop) for standardizing the SDMT and CVLT-II, as well as for receiving the study conditions via Zoom for Healthcare, registering for Fitabase, and email for receiving updates on study processes and communication with the study staff.
- Willingness to complete the measures and be randomized.
- Physical activity status: All participants must be insufficiently physically active, based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire (GLTEQ). This is necessary for minimizing potential ceiling effects of the intervention condition on physical activity.
- Ambulatory status: All participants will be able to walk without an assistive device, and have Patient-Determined Disease Steps (PDDS) scores between 0 and 2 for confirmation of being fully-ambulatory.
- Fall risk: All participants will not have fallen due to MS in the past 6 months (i.e., low fall risk).
- Age: All subjects will be between the ages of 18 and 65.
- Psychiatric status: Participants will not have uncontrolled major depression disorder or a history of other significant psychiatric disorders (e.g., bipolar disorder I or II, schizophrenia).
- Medications: Participants will not regularly be taking medications that can affect cognition, such as antipsychotics or benzodiazepines. Study staff will review self-reported medications to determine participant eligibility status.
- Contraindications for ET: We will exclude all individuals with moderate or high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise using the Physical Activity Readiness Questionnaire (PAR-Q). During the initial phone contact with Ms. Wells, participants will verbally respond to the 7-items on the PAR-Q, and those individuals who report one or fewer YES or affirmative responses on the seven PAR-Q items will be considered at low risk and included for participation. All other individuals will be considered at moderate or high risk for starting a physical activity program and excluded from participation.
- Severe cognitive impairment: Ms. Wells will administer the Telephone Interview for Cognitive Status (TICS-M) over the phone to ensure that all participants can adequately follow directions. In order to pass this inclusion criterion, participants must demonstrate TICS-M scores of 18 or higher. This is critical for ensuring that participants do not have severe cognitive impairment that might preclude the ability to adhere to the conditions, understand intervention content, and interact with the behavior coach.
If the prospective participant with MS passes the above screen, a second-level screening for CPS impairment will take place via Zoom:
- CPS impairment: All participants will demonstrate impairment in CPS based on Symbol Digit Modalities Test (SDMT) scores at least 1 SD below the age-adjusted normative score for healthy controls.
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive processing speed (CPS) impairment is prevalent, impactful, and poorly-managed in multiple sclerosis (MS). Upwards of 67% of patients present with MS-related CPS impairment, which is associated with poor everyday life outcomes. There are no FDA-approved pharmacological treatments for CPS impairment in MS. This landscape creates a critical public health and clinical crisis that underscores the importance of identifying efficacious approaches for managing CPS impairment in MS. We believe that aerobic exercise training represents a promising and powerful behavioral approach. This project involves a single-blind randomized controlled trial of 16-weeks of remotely-delivered and supported aerobic walking exercise training compared with an active control condition (remotely-delivered and supported stretching and toning activities) on CPS (assessed remotely) in 24 fully-ambulatory, but CPS-impaired persons with MS.
This pilot trial will be conducted in a fully-remote fashion, such that there are no required in-person visits to Kessler Foundation. Participants (N=24) will initially undertake baseline assessments 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. At this virtual study visit, participants further will undergo a neuropsychological test of verbal learning and complete questionnaires assessing physical activity and MS symptoms via computer (REDCap). Following baseline, participants will be randomly assigned into the remotely-delivered and supported aerobic walking exercise training intervention condition (n=12) or remotely-delivered and supported attention and social contact control condition (n=12) using concealment. Both conditions will be administered remotely over 16-weeks via telerehabilitation by a postdoctoral behavior coach during scheduled calls. Participants will undertake aerobic walking exercise training or stretching-and-toning in the home/community. The exercise training intervention involves aerobic walking exercise training that is monitored by a waist-worn FitBit and follows prescriptive guidelines for aerobic exercise for persons with MS. The control condition involves stretching-and-toning based on a manual published by the National Multiple Sclerosis Society. Both conditions further involve one-on-one coaching, action-planning via calendars, logs for self-monitoring, and newsletters based on Social Cognitive Theory. After the 16-week exercise/control period, participants will undergo remote assessments of CPS and verbal learning (administered by a treatment-blinded assessor) as well as completion of questionnaires assessing physical activity and MS symptoms via REDCap.
If successful, this RCT will provide preliminary data on the extent to which (a) remotely-delivered/supported aerobic walking ET results in significant CPS improvements in CPS-impaired persons with MS; and (b) the intervention results in increased physical activity relative to an active control in a cognitively-impaired cohort. These pilot data will be essential for supporting a large R01 application on a multi-site, effectiveness RCT in a nationwide sample of CPS-impaired persons with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Remotely Delivered and Supported Aerobic Walking Exercise Training, Remotely Delivered and Supported Stretching and Toning Exercise Training
- Keywords
- Exercise, Physical Activity, Cognition, Walking, Stretching
- 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.
Remotely Delivered and Supported Aerobic Walking Exercise TrainingBehavioural
This condition will include 16-weeks of remotely-delivered and supported aerobic walking exercise training based on guidelines for physical activity in persons with MS for general health benefits. Exercise intensities will be prescribed based on steps per exercise sessions from a waist-worn FitBit One™ (FitBit, Inc., San Francisco, CA).
The exercise program involves one-on-one semi-structured sessions with an MS exercise specialist (i.e., behavior coach) throughout the program. These sessions focus on exercise training guidance and oversight, discussion of the behavioral strategies of action planning and self-monitoring, and presentation and discussion of newsletters for optimizing exercise compliance.
Remotely Delivered and Supported Stretching and Toning Exercise TrainingBehavioural
The active, non-aerobic exercise condition will involve stretching-and-toning activities. These activities will be based on a manual provided by the National Multiple Sclerosis Society. Participants will be provided with necessary exercise equipment (e.g., yoga mat, FitBit), an instructional DVD, and a manual, log-book, calendar, and prescription for the stretching program. This program will be supplemented with periodic newsletters delivered electronically that highlight principles of behavior change, and video-chats with a behavior coach that provide motivation and social accountability. These occur on the same timeline and frequency as in the walking condition, but focus on constructs for stretching.
| Study group | Role | What they receive |
|---|---|---|
| Remotely Delivered and Supported Aerobic Walking Exercise Training | Experimental | Not described Receives: Behavioral: Remotely Delivered and Supported Aerobic Walking Exercise Training |
| Remotely Delivered and Supported Stretching and Toning | Active comparator | Not described Receives: Behavioral: Remotely Delivered and Supported Stretching and Toning Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Processing Speed
Cognitive processing speed will be measured using the Symbol Digit Modalities Test. The primary outcome measure is the total score.
Measured: 16 weeks
Secondary outcomes (1)
Change in Verbal Learning and Memory
Verbal learning and memory will be measured using the learning trials of the California Verbal Learning Test-II. The primary outcome measure is the total learning score.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start25 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 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
- NCT05344040
- Sponsor's protocol ID
- E-1197-22
- Acronym
- REACT-MS
- Status last verified
- Dec 2022
- First submitted
- 13 Apr 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Exercise Effects on Cognitive Processing Speed in Multiple Sclerosis: A Pilot Trial
- ClinicalTrials.gov ID
- NCT05344040
- Acronym / sponsor ID
- REACT-MS / E-1197-22
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, Physical Activity, Cognition, Walking, Stretching
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 25 Apr 2022 (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.
Cognitive processing speed (CPS) impairment is prevalent, impactful, and poorly-managed in multiple sclerosis (MS). Upwards of 67% of patients present with MS-related CPS impairment, which is associated with poor everyday life outcomes. There are no FDA-approved pharmacological treatments for CPS impairment in MS. This landscape creates a critical public health and clinical crisis that underscores the importance of identifying efficacious approaches for managing CPS impairment in MS. We believe that aerobic exercise training represents a promising and powerful behavioral approach. This project involves a single-blind randomized controlled trial of 16-weeks of remotely-delivered and supported aerobic walking exercise training compared with an active control condition (remotely-delivered and supported stretching and toning activities) on CPS (assessed remotely) in 24 fully-ambulatory, but CPS-impaired persons with MS.
This pilot trial will be conducted in a fully-remote fashion, such that there are no required in-person visits to Kessler Foundation. Participants (N=24) will initially undertake baseline assessments 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. At this virtual study visit, participants further will undergo a neuropsychological test of verbal learning and complete questionnaires assessing physical activity and MS symptoms via computer (REDCap). Following baseline, participants will be randomly assigned into the remotely-delivered and supported aerobic walking exercise training intervention condition (n=12) or remotely-delivered and supported attention and social contact control condition (n=12) using concealment. Both conditions will be administered remotely over 16-weeks via telerehabilitation by a postdoctoral behavior coach during scheduled calls. Participants will undertake aerobic walking exercise training or stretching-and-toning in the home/community. The exercise training intervention involves aerobic walking exercise training that is monitored by a waist-worn FitBit and follows prescriptive guidelines for aerobic exercise for persons with MS. The control condition involves stretching-and-toning based on a manual published by the National Multiple Sclerosis Society. Both conditions further involve one-on-one coaching, action-planning via calendars, logs for self-monitoring, and newsletters based on Social Cognitive Theory. After the 16-week exercise/control period, participants will undergo remote assessments of CPS and verbal learning (administered by a treatment-blinded assessor) as well as completion of questionnaires assessing physical activity and MS symptoms via REDCap.
If successful, this RCT will provide preliminary data on the extent to which (a) remotely-delivered/supported aerobic walking ET results in significant CPS improvements in CPS-impaired persons with MS; and (b) the intervention results in increased physical activity relative to an active control in a cognitively-impaired cohort. These pilot data will be essential for supporting a large R01 application on a multi-site, effectiveness RCT in a nationwide sample of CPS-impaired persons with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remotely Delivered and Supported Aerobic Walking Exercise Training | Experimental | Behavioral: Remotely Delivered and Supported Aerobic Walking Exercise Training |
| Remotely Delivered and Supported Stretching and Toning | Active comparator | Behavioral: Remotely Delivered and Supported Stretching and Toning Exercise Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Remotely Delivered and Supported Aerobic Walking Exercise TrainingThis condition will include 16-weeks of remotely-delivered and supported aerobic walking exercise training based on guidelines for physical activity in persons with MS for general health benefits. Exercise intensities will be prescribed based on steps per exercise sessions from a waist-worn FitBit One™ (FitBit, Inc., San Francisco, CA). The exercise program involves one-on-one semi-structured sessions with an MS exercise specialist (i.e., behavior coach) throughout the program. These sessions focus on exercise training guidance and oversight, discussion of the behavioral strategies of action planning and self-monitoring, and presentation and discussion of newsletters for optimizing exercise compliance. | Behavioural | Remotely Delivered and Supported Aerobic Walking Exercise Training |
| Remotely Delivered and Supported Stretching and Toning Exercise TrainingThe active, non-aerobic exercise condition will involve stretching-and-toning activities. These activities will be based on a manual provided by the National Multiple Sclerosis Society. Participants will be provided with necessary exercise equipment (e.g., yoga mat, FitBit), an instructional DVD, and a manual, log-book, calendar, and prescription for the stretching program. This program will be supplemented with periodic newsletters delivered electronically that highlight principles of behavior change, and video-chats with a behavior coach that provide motivation and social accountability. These occur on the same timeline and frequency as in the walking condition, but focus on constructs for stretching. | Behavioural | Remotely Delivered and Supported Stretching and Toning |
Primary outcome
Change in Cognitive Processing Speed
Time frame: 16 weeks
Cognitive processing speed will be measured using the Symbol Digit Modalities Test. The primary outcome measure is the total score.
1 secondary outcome
Change in Verbal Learning and Memory
Time frame: 16 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 5 Dec 2022.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing Remotely Delivered and Supported Aerobic Walking Exercise Training and Remotely Delivered and Supported Stretching and Toning Exercise Training in people with 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?
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 5 Dec 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Cognitive Processing Speed (time frame: 16 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 5 Dec 2022.