Multiple SclerosisNCT06355804
Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
A study testing Physical activity condition and Waitlist condition in people with Multiple Sclerosis, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physical activity condition and Waitlist condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 1 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older
- self-reported diagnosis of MS by a neurologist within the past 2 years
- relapse-free for the past 30 days
- ability to speak and read English as primary language
- internet and e-mail access, and willingness to complete the testing and questionnaires
- ambulatory without an assistive device (e.g., cane)
Show all 9Show fewer
- insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) < 14)
- visual ability and literacy to read newsletter with font size 14 points
- on a disease-modifying therapy.
Who cannot join
- pregnant
- have elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years).
Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention.
Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition.
Read the detailed description
Multiple sclerosis (MS) is a prevalent neurological disease of the central nervous system that is the leading cause of neurological disability among young adults in the United States. This disease results in the progressive loss of walking, substantial worsening of cognition, symptoms of fatigue, as well as compromised quality of life (QoL). There is evidence that physical activity is beneficially associated with walking mobility, cognitive function, symptoms of fatigue, depression, anxiety, and pain in persons with MS. Nonetheless, this population is strikingly sedentary and physically inactive, including persons newly diagnosed with MS (diagnosed with MS for two years or less). Indeed, approximately 40% of persons with MS reported stopping physical activity after an MS diagnosis, and persons recently diagnosed with MS have not been included in physical activity intervention research. Yet, the early stage of MS represents an ideal time point for initiating physical activity for life-long benefits. There is further evidence that physical activity and exercises interventions delivered remotely can yield benefits in managing MS symptoms and comorbidities, and disability progression. To this end, the objective of this current study is to examine the efficacy of a 16-week remotely delivered behavioral intervention, compared with a control condition (i.e., waitlist control), for increasing physical activity and improving secondary outcomes in persons newly diagnosed with MS (disease duration ≤ 2 years). Participants will complete a series of assessments of physical activity, MS symptoms, and physical and cognitive function before and immediately after the 16-week program. The assessments involve the completion of a battery of questionnaires remotely over the Internet. The investigators will also ask that participants wear an accelerometer (like a pedometer) during the waking hours of the day for a 7-day period as an assessment of physical activity. The first assessments occur upon enrollment in the study (Baseline Assessment) and the second occurs right after the intervention (16- week Assessment). In this study, participants will be randomly assigned into 1 of 2 conditions: a physical activity condition (receive the intervention immediately after baseline assessment) or a waitlist condition (receive the intervention after the 16-week assessment). Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom. The investigators will ask that participants in the physical activity condition wear a Fitbit (this is different from the accelerometer) for tracking physical activity daily during the 16- week period. The investigators will further ask that information from the Fitbit be recorded into a logbook daily.
- Conditions
- Multiple Sclerosis
- Being tested
- Physical activity condition, Waitlist condition
- Keywords
- Physical activity, Behavior change, Behavioral intervention
- 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.
Physical activity conditionBehavioural
Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach:
- The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels.
- Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity.
- The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS.
- The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded.
Waitlist conditionBehavioural
Participants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach:
- The newsletters provide information on the benefits of physical activity, goal setting and monitoring, and other behavioral strategies for increasing and maintaining physical activity levels.
- The newsletter will be emailed to participants weekly throughout the program.
- Content on the newsletter includes knowledge and skills related to physical activity in the early stages of MS, text of individuals with MS discussing their experiences, web links, worksheets, and brochures.
- The program also involves 7 one-on-one video coaching chats with a behavioral coach to guide participants through the program and navigate challenges. These chats are conducted face- to-face over Zoom and generally last about 15 - 30 minutes each. The investigators do not record these sessions.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity condition | Experimental | Participants in this arm will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15 - 30 minutes) over Zoom with a behavioral coach after the baseline assessment. Throughout the 16-week period, The investigators will ask participants to wear a Fitbit (provided) for tracking daily physical activity. Receives: Behavioral: Physical activity condition |
| Waitlist condition | Other | Participants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15-30 minutes) over Zoom with a behavioral coach after the follow-up assessment. Receives: Behavioral: Waitlist condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Behavior
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
Measured: Changes in the GLTEQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Behavior
International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
Measured: Changes in the IPAQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Level (Light physical activity)
Time (minutes/day) spent in light physical activity (LPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of LPA reflects a higher level of physical activity.
Measured: Changes in time spent in LPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Level (Moderate-to-vigorous physical activity)
Time (minutes/day) spent in moderate-to-vigorous physical activity (MVPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of MVPA reflects a higher level of physical activity.
Measured: Changes in time spent in MVPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Level (Daily step count)
Daily step count will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a greater number of steps per day reflects a higher level of physical activity.
Measured: Changes in time spent in daily step count from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Secondary outcomes (5)
Health-related quality of Life
Short Form Health Status Survey (SF-12); scores range between 0 (min) and 100 (max), higher scores indicate better physical and mental aspects of quality of life.
Measured: Changes in SF-12 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Health-related Quality of Life
Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes).
Measured: Changes in MSIS-29 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Measured: Changes in fatigue severity scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Depressive Symptoms
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Measured: Changes in depressive symptoms scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Anxiety
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Measured: Changes in anxiety scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start29 Apr 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (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 University of Illinois ChicagoThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert W Motl, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355804
- Sponsor's protocol ID
- STUDY2023-1565
- Status last verified
- Sep 2025
- First submitted
- 27 Mar 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06355804
- Acronym / sponsor ID
- STUDY2023-1565
- Conditions
- Multiple Sclerosis
- Keywords
- Physical activity, Behavior change, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (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.
The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years).
Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention.
Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition.
Detailed description
Multiple sclerosis (MS) is a prevalent neurological disease of the central nervous system that is the leading cause of neurological disability among young adults in the United States. This disease results in the progressive loss of walking, substantial worsening of cognition, symptoms of fatigue, as well as compromised quality of life (QoL). There is evidence that physical activity is beneficially associated with walking mobility, cognitive function, symptoms of fatigue, depression, anxiety, and pain in persons with MS. Nonetheless, this population is strikingly sedentary and physically inactive, including persons newly diagnosed with MS (diagnosed with MS for two years or less). Indeed, approximately 40% of persons with MS reported stopping physical activity after an MS diagnosis, and persons recently diagnosed with MS have not been included in physical activity intervention research. Yet, the early stage of MS represents an ideal time point for initiating physical activity for life-long benefits. There is further evidence that physical activity and exercises interventions delivered remotely can yield benefits in managing MS symptoms and comorbidities, and disability progression. To this end, the objective of this current study is to examine the efficacy of a 16-week remotely delivered behavioral intervention, compared with a control condition (i.e., waitlist control), for increasing physical activity and improving secondary outcomes in persons newly diagnosed with MS (disease duration ≤ 2 years). Participants will complete a series of assessments of physical activity, MS symptoms, and physical and cognitive function before and immediately after the 16-week program. The assessments involve the completion of a battery of questionnaires remotely over the Internet. The investigators will also ask that participants wear an accelerometer (like a pedometer) during the waking hours of the day for a 7-day period as an assessment of physical activity. The first assessments occur upon enrollment in the study (Baseline Assessment) and the second occurs right after the intervention (16- week Assessment). In this study, participants will be randomly assigned into 1 of 2 conditions: a physical activity condition (receive the intervention immediately after baseline assessment) or a waitlist condition (receive the intervention after the 16-week assessment). Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom. The investigators will ask that participants in the physical activity condition wear a Fitbit (this is different from the accelerometer) for tracking physical activity daily during the 16- week period. The investigators will further ask that information from the Fitbit be recorded into a logbook daily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity condition | Experimental | Behavioral: Physical activity conditionParticipants in this arm will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15 - 30 minutes) over Zoom with a behavioral coach after the baseline assessment. Throughout the 16-week period, The investigators will ask participants to wear a Fitbit (provided) for tracking daily physical activity. |
| Waitlist condition | Other | Behavioral: Waitlist conditionParticipants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15-30 minutes) over Zoom with a behavioral coach after the follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- aged 18 years or older
- self-reported diagnosis of MS by a neurologist within the past 2 years
- relapse-free for the past 30 days
- ability to speak and read English as primary language
- internet and e-mail access, and willingness to complete the testing and questionnaires
Key exclusion criteria (2 listed)
- pregnant
- have elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)
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 |
|---|---|---|
| Physical activity conditionParticipants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: * The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels. * Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity. * The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS. * The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded. | Behavioural | Physical activity condition |
| Waitlist conditionParticipants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: * The newsletters provide information on the benefits of physical activity, goal setting and monitoring, and other behavioral strategies for increasing and maintaining physical activity levels. * The newsletter will be emailed to participants weekly throughout the program. * Content on the newsletter includes knowledge and skills related to physical activity in the early stages of MS, text of individuals with MS discussing their experiences, web links, worksheets, and brochures. * The program also involves 7 one-on-one video coaching chats with a behavioral coach to guide participants through the program and navigate challenges. These chats are conducted face- to-face over Zoom and generally last about 15 - 30 minutes each. The investigators do not record these sessions. | Behavioural | Waitlist condition |
Primary outcome
Physical Activity Behavior
Time frame: Changes in the GLTEQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
Physical Activity Behavior
Time frame: Changes in the IPAQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
Physical Activity Level (Light physical activity)
Time frame: Changes in time spent in LPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Time (minutes/day) spent in light physical activity (LPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of LPA reflects a higher level of physical activity.
Physical Activity Level (Moderate-to-vigorous physical activity)
Time frame: Changes in time spent in MVPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Time (minutes/day) spent in moderate-to-vigorous physical activity (MVPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of MVPA reflects a higher level of physical activity.
Physical Activity Level (Daily step count)
Time frame: Changes in time spent in daily step count from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Daily step count will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a greater number of steps per day reflects a higher level of physical activity.
5 secondary outcomes
Health-related quality of Life
Time frame: Changes in SF-12 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Health-related Quality of Life
Time frame: Changes in MSIS-29 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Fatigue Severity
Time frame: Changes in fatigue severity scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Depressive Symptoms
Time frame: Changes in depressive symptoms scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Anxiety
Time frame: Changes in anxiety scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
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 17 Sep 2025.
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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 study testing Physical activity condition and Waitlist condition in people with Multiple Sclerosis, run by University of Illinois Chicago 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 9 inclusion and 2 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 17 Sep 2025. 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?
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?
Physical Activity Behavior (time frame: Changes in the GLTEQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)). The study lists 5 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 17 Sep 2025; AzTrials last refreshed its copy on 2 Nov 2026.