Multiple SclerosisTEAAMSNCT05516537
Examining the Effects of a Remotely-delivered, Racially-tailored Exercise Training Program for Immediate and Sustained Improvements in Walking Dysfunction, Symptoms, and Health-related Quality of Life (HRQOL) Among African-Americans With Multiple Sclerosis (MS) Residing in Rural Environments.
A study testing Guidelines for Exercise in Multiple Sclerosis (GEMS) and FLEX Stretching and Toning Program in people with Multiple Sclerosis, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans… 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?
- Guidelines for Exercise in Multiple Sclerosis (GEMS) and FLEX Stretching and Toning Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2022to 30 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English as primary language
- Identify as African-American or Black
- Age of 18 years or older
- Diagnosis of MS
- Relapse free in the past 30 days
- Internet and email access
Show all 10Show fewer
- Willingness to complete the outcome questionnaires
- Willingness to undergo randomization
- Insufficient physical activity (not meeting current physical activity guidelines based on GLTEQ)
- Mild-moderate ambulatory disability (MSWS-12 score between 25-49 \& PDDS score between 2-4)
Who cannot join
- Individuals not meeting above inclusion criteria
- Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with MS residing in rural environments. The primary analysis will test the hypothesis that those who are randomly assigned into the intervention condition (i.e., exercise training) will demonstrate (a) improvements in outcomes from baseline that (b) are sustained over 4-months of follow-up compared with those in the control condition (i.e., stretching).
Read the detailed description
There is a lack of evidence from high-quality randomized controlled trials (RCTs) of exercise training for African-Americans with multiple sclerosis (MS), as only 1.7% of participants in physical activity and exercise research involving persons with MS identify as African-American. The population of African-Americans with MS deserves equal and focal research that addresses the unique challenges of MS in the African-American rural residing community. We uniquely address this population with a highly-developed and refined exercise training program that is racially-tailored for the target population. We further provide a highly-developed and refined exercise training program that can be undertaken in one's home and/or local community, and does not require facility access that is extremely limited in the target, rural residing population of persons with MS. The program is further tailored based on qualitative research and addresses the unique needs of the African-American community with MS. There is no other research program this advanced in study refinement and design for immediate integration into a high-quality RCT for changing the lives of African-Americans with MS who reside in rural communities of the Southeastern portion of the United States. If successful, the study, as designed, will provide Class I evidence that is necessary for immediate implementation after trial completion through insurance providers and healthcare providers, including physical therapists, rehabilitation practitioners, and community health workers/providers. This program further aligns with recently developed and highly-refined conceptual and practice models for implementation of exercise into the care of persons with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Guidelines for Exercise in Multiple Sclerosis (GEMS), FLEX Stretching and Toning Program
- Keywords
- Rural, Walking dysfunction, Health-Related Quality of Life, African-American
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidelines for Exercise in Multiple Sclerosis (GEMS)Behavioural
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training.
FLEX Stretching and Toning ProgramBehavioural
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training.
| Study group | Role | What they receive |
|---|---|---|
| Guidelines for Exercise in Multiple Sclerosis (GEMS) | Experimental | Participants in this condition will receive a 4-month home-based, remotely supported aerobic and resistance exercise program based on the Guidelines for Exercise in Multiple Sclerosis (GEMS). Receives: Behavioral: Guidelines for Exercise in Multiple Sclerosis (GEMS) |
| FLEX Stretching and Toning Program | Sham comparator | Participants in this condition will receive a 4-month home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society. Receives: Behavioral: FLEX Stretching and Toning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Dysfunction
Multiple Sclerosis Walking Scale-12 (MSWS-12); scores range between 0 (min) and 100 (max), higher scores reflect greater walking problems.
Measured: Changes in walking scores from Baseline, 4-months, and 8-months.
Secondary outcomes (5)
Disability
Patient Determined Disease Steps (PDDS) scale; scores range between 0 (min) and 8 (max), higher score reflect greater perceived disability.
Measured: Changes in disability scores from Baseline, 4-months, and 8 months.
Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Measured: Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
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 from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
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 symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Health-related Quality of Life (HRQOL)
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 quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start2 Sep 2022
- Primary completion31 Dec 2025
- Study completion30 Jan 2026
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Bristol-Myers Squibb
- Responsible party
- Principal investigator, Robert W Motl, University of Illinois Chicago
- Investigators
- Robert W Motl, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516537
- Sponsor's protocol ID
- 2022-0526
- Other IDs
- 20016
- Acronym
- TEAAMS
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2022
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05516537
- Acronym / sponsor ID
- TEAAMS / 2022-0526
- Conditions
- Multiple Sclerosis
- Keywords
- Rural, Walking dysfunction, Health-Related Quality of Life, African-American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Bristol-Myers Squibb
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 25 Aug 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.
The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with MS residing in rural environments. The primary analysis will test the hypothesis that those who are randomly assigned into the intervention condition (i.e., exercise training) will demonstrate (a) improvements in outcomes from baseline that (b) are sustained over 4-months of follow-up compared with those in the control condition (i.e., stretching).
Detailed description
There is a lack of evidence from high-quality randomized controlled trials (RCTs) of exercise training for African-Americans with multiple sclerosis (MS), as only 1.7% of participants in physical activity and exercise research involving persons with MS identify as African-American. The population of African-Americans with MS deserves equal and focal research that addresses the unique challenges of MS in the African-American rural residing community. We uniquely address this population with a highly-developed and refined exercise training program that is racially-tailored for the target population. We further provide a highly-developed and refined exercise training program that can be undertaken in one's home and/or local community, and does not require facility access that is extremely limited in the target, rural residing population of persons with MS. The program is further tailored based on qualitative research and addresses the unique needs of the African-American community with MS. There is no other research program this advanced in study refinement and design for immediate integration into a high-quality RCT for changing the lives of African-Americans with MS who reside in rural communities of the Southeastern portion of the United States. If successful, the study, as designed, will provide Class I evidence that is necessary for immediate implementation after trial completion through insurance providers and healthcare providers, including physical therapists, rehabilitation practitioners, and community health workers/providers. This program further aligns with recently developed and highly-refined conceptual and practice models for implementation of exercise into the care of persons with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guidelines for Exercise in Multiple Sclerosis (GEMS) | Experimental | Behavioral: Guidelines for Exercise in Multiple Sclerosis (GEMS)Participants in this condition will receive a 4-month home-based, remotely supported aerobic and resistance exercise program based on the Guidelines for Exercise in Multiple Sclerosis (GEMS). |
| FLEX Stretching and Toning Program | Sham comparator | Behavioral: FLEX Stretching and Toning ProgramParticipants in this condition will receive a 4-month home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- English as primary language
- Identify as African-American or Black
- Age of 18 years or older
- Diagnosis of MS
- Relapse free in the past 30 days
Key exclusion criteria (2 listed)
- Individuals not meeting above inclusion criteria
- Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ).
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 |
|---|---|---|
| Guidelines for Exercise in Multiple Sclerosis (GEMS)Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training. | Behavioural | Guidelines for Exercise in Multiple Sclerosis (GEMS) |
| FLEX Stretching and Toning ProgramRemotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training. | Behavioural | FLEX Stretching and Toning Program |
Primary outcome
Walking Dysfunction
Time frame: Changes in walking scores from Baseline, 4-months, and 8-months.
Multiple Sclerosis Walking Scale-12 (MSWS-12); scores range between 0 (min) and 100 (max), higher scores reflect greater walking problems.
5 secondary outcomes
Disability
Time frame: Changes in disability scores from Baseline, 4-months, and 8 months.
Fatigue Severity
Time frame: Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Depressive Symptoms
Time frame: Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Anxiety
Time frame: Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Health-related Quality of Life (HRQOL)
Time frame: Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
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 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
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.
Robert W Motl, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidelines for Exercise in Multiple Sclerosis (GEMS) and FLEX Stretching and Toning Program 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 10 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: finished, as of the sponsor's last update on 4 Jun 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. Some participants in this study may receive a placebo. 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?
Walking Dysfunction (time frame: Changes in walking scores from Baseline, 4-months, and 8-months.). 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 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.