Multiple SclerosisFERLAMSNCT05998616
Feasibility of Remote Exercise Training for Hispanics/Latinos With MS
A study testing Exercise Training Program and Flexibility Program in people with Multiple Sclerosis, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate the potential benefits of a specially designed exercise program for Hispanics/Latinos with multiple sclerosis (MS). The main questions it aims to answer are: Can a 4-month remotely-delivered exercise training program improve physical function, symptom management, and… 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?
- Exercise Training Program and Flexibility Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age between 18-65 years
- Diagnosis of MS
- Relapse-free for at least 30 days
- Able to walk with or without an assistive device
- Insufficient physical activity (i.e., not meeting current physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week)
- Willingness to complete all required testing procedures, outcome questionnaires, and randomization
Show all 11Show fewer
- Identify as Hispanic/Latino
- Able to speak, read, and understand English
- Currently reside in Chicago
- Access to the internet and email
- Safe for exercise based on the Physical Activity Readiness Questionnaire (PAR-Q)
Who cannot join
- Not between 18-65 years
- No diagnosis of MS
- Not relapse-free for at least 30 days
- Not able to walk with or without an assistive device
- Too much physical activity (i.e. 150 minutes or more of moderate to vigorous physical activity per week)
- Not willing to complete all required testing procedures, outcome questionnaires, and randomization
Show all 11Show fewer
- Do not identify as Hispanic/Latino
- Unable to speak, read, and understand English
- Not currently residing in Chicago
- No access to the internet and email
- Not safe for exercise based on the PAR-Q
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: The Feasibility and Efficacy of a Remotely Delivered Exercise Training Intervention for the Hispanic/Latino Community With Multiple Sclerosis
The goal of this clinical trial is to investigate the potential benefits of a specially designed exercise program for Hispanics/Latinos with multiple sclerosis (MS). The main questions it aims to answer are:
- Can a 4-month remotely-delivered exercise training program improve physical function, symptom management, and quality of life in Hispanics/Latinos with MS?
- How do social determinants of health, such as income, education, access to healthcare, and social support, influence the feasibility and effectiveness of the exercise intervention?
Participants in this study will engage in a 4-month remotely-delivered exercise training intervention that includes flexibility, or aerobic and resistance exercise training sessions. They will work with experienced coaches who will guide and support them throughout the program. The researchers will compare the participants who receive the exercise intervention with a control group to see if the exercise program leads to significant improvements in physical function, fatigue, mood, and overall well-being for Hispanics/Latinos with MS. The study aims to empower this underserved population and provide insights for future healthcare and research initiatives.
Read the detailed description
The FERLA MS study is a randomized controlled trial aimed at investigating the feasibility and effectiveness of a remotely-delivered exercise training intervention for Hispanics/Latinos with MS. This study aims also aims to address the significant health disparities faced by this underserved population and provide insights into the potential benefits of exercise training in managing MS symptoms and improving quality of life.
Multiple sclerosis (MS) is an autoimmune disease of the central nervous system, affecting millions of adults in the United States. Hispanics/Latinos with MS are particularly vulnerable to more aggressive disease progression and greater long-term disability compared to other racial/ethnic groups. These disparities are likely influenced by social determinants of health (SDOH), such as limited access to healthcare, medical services, and underrepresentation in medical research. The FERLA MS study seeks to explore the role of exercise training as a disease-modifying and symptom-managing intervention for enhancing health outcomes and overall well-being in this marginalized population.
The study has three main aims:
Aim #1: Assess the Feasibility of the Exercise Intervention. This aim focuses on evaluating the feasibility of a 4-month remotely-delivered exercise training intervention for Hispanics/Latinos with MS. The research team will assess the process, resource, management, and scientific measures to determine the practicality, safety, and efficacy of the intervention.
Aim #2: Evaluate the Efficacy of the Exercise Intervention. The second aim involves evaluating the effectiveness of the exercise intervention in improving physical function, symptom management, and overall quality of life compared to an active control condition. Specific outcomes include the 30-second sit-to-stand test, neuropsychological measures of cognition, fatigue, depression, anxiety, and self-reported health-related quality of life.
Aim #3: Explore the Impact of SDOH Factors. The third aim is to explore the influence of SDOH, such as income, education, access to healthcare, and social support, on the feasibility and potential efficacy of the exercise intervention for improving outcomes in Hispanics/Latinos with MS.
The study is guided by the following hypotheses:
Hypothesis 1: The remotely-delivered exercise training intervention will be feasible for Hispanics/Latinos with MS, as evidenced by high recruitment, enrollment, adherence, and retention rates, along with reasonable time, space, and monetary costs, and safe and effective delivery leading to improvements in MS symptoms and outcomes.
Hypothesis 2: Participants in the intervention condition will demonstrate significant improvements in physical function, cognition, fatigue, mood, and quality of life compared to the active control.
Hypothesis 3: Social determinants of health will significantly influence the feasibility and effectiveness of the exercise intervention in improving physical and mental health outcomes for Hispanics/Latinos with MS.
The FERLA MS study follows a parallel group, randomized controlled trial design. Eligible participants will be randomly assigned to either the remotely-delivered exercise intervention condition or the control condition. The exercise intervention will be based on the Guidelines for Exercise in Multiple Sclerosis (GEMS) and will include both aerobic and resistance training sessions. Aerobic Exercise: Participants will engage in moderate-intensity walking for 30+ minutes three days per week. The progression of the aerobic exercise will follow different trajectories based on individual needs and abilities. Resistance Exercise: The resistance training will consist of 1-2 sets of 10-15 repetitions of 5-10 exercises targeting different muscle groups, performed three days per week using elastic resistance bands. One-on-One Coaching: The exercise program involves one-on-one semi-structured sessions with MS exercise specialists (behavioral coaches) who will provide guidance, oversight, and support to participants. Coaches will also help with action planning, self-monitoring, and deliver content-relevant newsletters based on social cognitive theory. Control Condition: Participants in the control condition will engage in flexibility exercises through telerehabilitation, aimed at improving range of motion and stretching.
The primary endpoint is the feasibility of the remotely-delivered exercise program. Secondary outcomes include physical function, cognitive function, fatigue, mood, and health-related quality of life. The study will also explore the impact of social determinants of health as tertiary outcomes.
Participants' total time commitment for the study will be approximately 5 months, including recruitment, screening, baseline measures, the 4-month exercise or control intervention, and post-intervention measures. Enrollment duration for all study subjects is anticipated to take approximately 2-3 months, with the study projected to be completed by December 1, 2024. Participants must be aged between 18-65 years, diagnosed with MS, relapse-free for at least 30 days, able to walk with or without an assistive device, have no contraindications to exercise, and self-identify as Hispanic/Latino. Individuals with severe cognitive impairments, other neurological conditions, or medical conditions limiting exercise participation will be excluded.
The FERLA MS study will be conducted in compliance with all relevant institutional review board (IRB) regulations and ethical principles outlined in the Declaration of Helsinki. Participants will provide informed consent before enrollment, and all data will be kept confidential and anonymized to protect participants' privacy.
The study findings will be disseminated through peer-reviewed publications, scientific conferences, and presentations to the public, healthcare providers, and patient advocacy groups. The research team aims to leverage the study results to promote awareness, inform clinical practice, and advocate for more equitable access to healthcare and evidence-based interventions for Hispanics/Latinos with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise Training Program, Flexibility Program
- Keywords
- Multiple Sclerosis, Hispanics/Latinos, Exercise Intervention, Remote Exercise Training, Feasibility Study, Randomized Controlled Trial, Health Disparities, Social Determinants of Health, Physical Function, Cognitive Function, Fatigue, Quality of Life, Telerehabilitation, Health Equity
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training ProgramBehavioural
The intervention group will be encouraged to complete aerobic and resistance training exercises three times a week, and either at home, in the community (e.g., park, shopping mall), or any suitable environment of the participant's choice. Exercise equipment for monitoring walking and complete resistance training will be provided to the intervention group. The exercise training prescription involves 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and resistance training consisting of 1-2 sets, 10-15 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands.
Flexibility ProgramBehavioural
The control group will be encouraged to complete stretching and range of motion exercises three times a week, and either at home, in the community (e.g., park, shopping mall), or any suitable environment of the participant's choice. Exercise equipment (yoga mat) for monitoring walking and complete flexibility training will be provided to the control group. The flexibility training prescription involves stretches from the Stretching for People with MS: An Illustrated Manual from the National MS Society.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training Program | Experimental | Participants will receive a theory-based, remotely-delivered exercise training program that includes aerobic and resistance exercise training. Receives: Behavioral: Exercise Training Program |
| Flexibility Program | Active comparator | Participants will receive a remotely-delivered flexibility program, focusing on improving flexibility and range of motion. Receives: Behavioral: Flexibility Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Process: Participant Recruitment and Retention
Participant retention during the 16-week intervention period, reported as number of randomized participants who completed or did not complete the assigned program by study arm.
Measured: Before, During, and After 16 weeks, pre-, intra- and post-Intervention
Secondary outcomes (7)
Lower Extremity Function
Lower extremity function assessed by the 30-second sit-to-stand test (30STS). Values shown are adjusted post-intervention means from ANCOVA models controlling for baseline value, age, sex, and education. Higher scores indicate better lower extremity function.
Measured: Post-intervention at 16 weeks
Visual Processing Speed
Visual processing speed was assessed using the Symbol Digit Modalities Test (SDMT). Participants were shown a key pairing symbols with numbers and were asked to verbally identify the number corresponding to each symbol as quickly as possible. The outcome is the total number of correct responses completed in 90 seconds. Higher values indicate better visual processing speed. Values shown are adjusted post-intervention means from ANCOVA models controlling for baseline SDMT score, age, sex, and education. The raw score ranges from 0 to 110 points.
Measured: Post-intervention at 16 weeks
Verbal Learning and Memory
Verbal learning and memory assessed by the California Verbal Learning Test II (CVLT-II). A list of 16 words was read aloud by the examiner and participants were asked to immediately recall as many of the words as possible, in any order. Five trials were given, and the same list of words were read aloud by the examiner at the beginning of each trial. The number of correct responses from each trial 1 through 5 (T1 to T5) was summed for a total score out of 80 max (range 0-80). Values shown are adjusted post-intervention means from ANCOVA models controlling for baseline value, age, sex, and education. Higher scores indicate better verbal learning and memory.
Measured: Post-intervention at 16 weeks
Fatigue Severity
Fatigue severity assessed by the Fatigue Severity Scale (FSS). Values shown are adjusted post-intervention means from ANCOVA models controlling for baseline value, age, sex, and education. Scores range from 1 to 7, with higher scores indicating greater fatigue severity.
Measured: Post-intervention at 16 weeks
Depression and Anxiety Symptoms
Depression and Anxiety symptoms were assessed by the Hospital Anxiety and Depression Scale Depression subscale (HADS-Depression and HADS-Anxiety). Values shown are adjusted post-intervention means from ANCOVA models controlling for baseline value, age, sex, and education. The HADS includes 14 items which can be subscored for depression (7 items) and anxiety (7 items) as separate measures. Statements in the scale are self-reported by participants as experienced "Most of the time", "A lot of the time", "From time to time, occasionally", or "Not at all". Scores for anxiety and depression subscales range from 0-21 and are categorized as 'normal' (0-7), 'mild' (8-10), 'moderate' (11-14), and 'severe' (15-21). Overall, scores range from 0 to 42 with higher scores indicating higher anxious and depressive symptoms.
Measured: Post-intervention at 16 weeks
Exercise Behavior
Exercise behavior was assessed by Godin Leisure-Time Exercise Questionnaire (GLTEQ) total (TOT) and health contribution scores (HCS). GLTEQ TOT includes all 3 activity intensity categories (strenuous, moderate, and mild), and GLTEQ HCS with 2 (strenuous and moderate). Both scores are derived from the same frequency data (# of times per week for each activity type) and the same point values for each intensity level. Since mild activity contributes only 3 points per occurrence, removing it in the GLTEQ HCS calculation shifts the total upward but does not change the maximum possible value. The highest possible GLTEQ TOT score (999) is also the highest possible GLTEQ HCS score, and the lowest possible TOT (0) is the same as the lowest possible HCS score (0). For both, higher scores indicate greater exercise participation and represent a better outcome; lower scores indicate less exercise participation and represent a worse outcome.
Measured: Post-intervention at 16 weeks
Health-related Quality of Life
Health-related Quality of Life assessed by the Short Form -12 (SF-12), a shortened version of the short-form 36-item health survey, which measures overall health status. There are 2 composite scores, physical component summary (PCS) and mental component summary (MCS), reported as T-scores, that reflect overall perceived physical and mental health status, respectively. Both components are qualitatively measured and adjusted based on relative average (general average population is 50 with a standard deviation of 10). Both PCS and MCS T-scores are norm-based; the US population average is 50 with a standard deviation of 10. PCS and MCS T-scores above 50 are considered above average and scores below 50 are considered below average. Values shown are adjusted post-intervention means from ANCOVA models controlling for baseline value, age, sex, and education.
Measured: Post-intervention at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start27 Apr 2024
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Why it stopped: The study was terminated early due to NIH funding withdrawal before reaching the planned sample size of 50 participants. Thirty-three participants enrolled, 30 were randomized, and 26 completed follow-up assessments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- FERLA MS is a parallel-group, randomized controlled trial, where eligible participants with MS will be randomly assigned to either the remotely-delivered exercise intervention group or the remotely-delivered and supported flexibility control group. Both groups will receive intervention materials and support via teleconferencing or phone calls. The exercise group will follow a theory-based aerobic and resistance training program, while the control group will engage in flexibility exercises.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Robert W Motl, University of Illinois Chicago
- Investigators
- Robert Motl, Ph.D, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998616
- Sponsor's protocol ID
- Study2023-0665
- Other IDs
- P50MD017349
- Acronym
- FERLAMS
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2023
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flores VA, Silveira SL, Marquez DX, Kinnett-Hopkins D, Miravalle A, Sierra-Morales F, Motl RW. Feasibility and preliminary outcomes of a remotely-delivered exercise training intervention for English-speaking Hispanics/Latinos with multiple sclerosis: Results from the FERLA MS study. Mult Scler J Exp Transl Clin. 2026 Apr 30;12(2):20552173261448001. doi: 10.1177/20552173261448001. eCollection 2026 Apr-Jun.
PubMed 42112098Flores VA, Silveira SL, Marquez DX, Kinnett-Hopkins D, Miravalle A, Sierra-Morales F, Hernandez-Peraza Z, Motl RW. Rationale for a 4-month, parallel-group, randomized controlled trial to assess the Feasibility and Efficacy of a Remotely delivered exercise training intervention for Hispanics/Latinos with Multiple Sclerosis (FERLA MS). Pilot Feasibility Stud. 2025 May 8;11(1):62. doi: 10.1186/s40814-025-01641-5.
PubMed 40340698
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Efficacy of a Remotely Delivered Exercise Training Intervention for the Hispanic/Latino Community With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05998616
- Acronym / sponsor ID
- FERLAMS / Study2023-0665
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Hispanics/Latinos, Exercise Intervention, Remote Exercise Training, Feasibility Study, Randomized Controlled Trial, Health Disparities, Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to NIH funding withdrawal before reaching the planned sample size of 50 participants. Thirty-three participants enrolled, 30 were randomized, and 26 completed follow-up assessments.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the potential benefits of a specially designed exercise program for Hispanics/Latinos with multiple sclerosis (MS). The main questions it aims to answer are:
- Can a 4-month remotely-delivered exercise training program improve physical function, symptom management, and quality of life in Hispanics/Latinos with MS?
- How do social determinants of health, such as income, education, access to healthcare, and social support, influence the feasibility and effectiveness of the exercise intervention?
Participants in this study will engage in a 4-month remotely-delivered exercise training intervention that includes flexibility, or aerobic and resistance exercise training sessions. They will work with experienced coaches who will guide and support them throughout the program. The researchers will compare the participants who receive the exercise intervention with a control group to see if the exercise program leads to significant improvements in physical function, fatigue, mood, and overall well-being for Hispanics/Latinos with MS. The study aims to empower this underserved population and provide insights for future healthcare and research initiatives.
Detailed description
The FERLA MS study is a randomized controlled trial aimed at investigating the feasibility and effectiveness of a remotely-delivered exercise training intervention for Hispanics/Latinos with MS. This study aims also aims to address the significant health disparities faced by this underserved population and provide insights into the potential benefits of exercise training in managing MS symptoms and improving quality of life.
Multiple sclerosis (MS) is an autoimmune disease of the central nervous system, affecting millions of adults in the United States. Hispanics/Latinos with MS are particularly vulnerable to more aggressive disease progression and greater long-term disability compared to other racial/ethnic groups. These disparities are likely influenced by social determinants of health (SDOH), such as limited access to healthcare, medical services, and underrepresentation in medical research. The FERLA MS study seeks to explore the role of exercise training as a disease-modifying and symptom-managing intervention for enhancing health outcomes and overall well-being in this marginalized population.
The study has three main aims:
Aim #1: Assess the Feasibility of the Exercise Intervention. This aim focuses on evaluating the feasibility of a 4-month remotely-delivered exercise training intervention for Hispanics/Latinos with MS. The research team will assess the process, resource, management, and scientific measures to determine the practicality, safety, and efficacy of the intervention.
Aim #2: Evaluate the Efficacy of the Exercise Intervention. The second aim involves evaluating the effectiveness of the exercise intervention in improving physical function, symptom management, and overall quality of life compared to an active control condition. Specific outcomes include the 30-second sit-to-stand test, neuropsychological measures of cognition, fatigue, depression, anxiety, and self-reported health-related quality of life.
Aim #3: Explore the Impact of SDOH Factors. The third aim is to explore the influence of SDOH, such as income, education, access to healthcare, and social support, on the feasibility and potential efficacy of the exercise intervention for improving outcomes in Hispanics/Latinos with MS.
The study is guided by the following hypotheses:
Hypothesis 1: The remotely-delivered exercise training intervention will be feasible for Hispanics/Latinos with MS, as evidenced by high recruitment, enrollment, adherence, and retention rates, along with reasonable time, space, and monetary costs, and safe and effective delivery leading to improvements in MS symptoms and outcomes.
Hypothesis 2: Participants in the intervention condition will demonstrate significant improvements in physical function, cognition, fatigue, mood, and quality of life compared to the active control.
Hypothesis 3: Social determinants of health will significantly influence the feasibility and effectiveness of the exercise intervention in improving physical and mental health outcomes for Hispanics/Latinos with MS.
The FERLA MS study follows a parallel group, randomized controlled trial design. Eligible participants will be randomly assigned to either the remotely-delivered exercise intervention condition or the control condition. The exercise intervention will be based on the Guidelines for Exercise in Multiple Sclerosis (GEMS) and will include both aerobic and resistance training sessions. Aerobic Exercise: Participants will engage in moderate-intensity walking for 30+ minutes three days per week. The progression of the aerobic exercise will follow different trajectories based on individual needs and abilities. Resistance Exercise: The resistance training will consist of 1-2 sets of 10-15 repetitions of 5-10 exercises targeting different muscle groups, performed three days per week using elastic resistance bands. One-on-One Coaching: The exercise program involves one-on-one semi-structured sessions with MS exercise specialists (behavioral coaches) who will provide guidance, oversight, and support to participants. Coaches will also help with action planning, self-monitoring, and deliver content-relevant newsletters based on social cognitive theory. Control Condition: Participants in the control condition will engage in flexibility exercises through telerehabilitation, aimed at improving range of motion and stretching.
The primary endpoint is the feasibility of the remotely-delivered exercise program. Secondary outcomes include physical function, cognitive function, fatigue, mood, and health-related quality of life. The study will also explore the impact of social determinants of health as tertiary outcomes.
Participants' total time commitment for the study will be approximately 5 months, including recruitment, screening, baseline measures, the 4-month exercise or control intervention, and post-intervention measures. Enrollment duration for all study subjects is anticipated to take approximately 2-3 months, with the study projected to be completed by December 1, 2024. Participants must be aged between 18-65 years, diagnosed with MS, relapse-free for at least 30 days, able to walk with or without an assistive device, have no contraindications to exercise, and self-identify as Hispanic/Latino. Individuals with severe cognitive impairments, other neurological conditions, or medical conditions limiting exercise participation will be excluded.
The FERLA MS study will be conducted in compliance with all relevant institutional review board (IRB) regulations and ethical principles outlined in the Declaration of Helsinki. Participants will provide informed consent before enrollment, and all data will be kept confidential and anonymized to protect participants' privacy.
The study findings will be disseminated through peer-reviewed publications, scientific conferences, and presentations to the public, healthcare providers, and patient advocacy groups. The research team aims to leverage the study results to promote awareness, inform clinical practice, and advocate for more equitable access to healthcare and evidence-based interventions for Hispanics/Latinos with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- FERLA MS is a parallel-group, randomized controlled trial, where eligible participants with MS will be randomly assigned to either the remotely-delivered exercise intervention group or the remotely-delivered and supported flexibility control group. Both groups will receive intervention materials and support via teleconferencing or phone calls. The exercise group will follow a theory-based aerobic and resistance training program, while the control group will engage in flexibility exercises.
| Arm | Type | Receives |
|---|---|---|
| Exercise Training Program | Experimental | Behavioral: Exercise Training ProgramParticipants will receive a theory-based, remotely-delivered exercise training program that includes aerobic and resistance exercise training. |
| Flexibility Program | Active comparator | Behavioral: Flexibility ProgramParticipants will receive a remotely-delivered flexibility program, focusing on improving flexibility and range of motion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18-65 years
- Diagnosis of MS
- Relapse-free for at least 30 days
- Able to walk with or without an assistive device
- Insufficient physical activity (i.e., not meeting current physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week)
Key exclusion criteria (11 listed)
- Not between 18-65 years
- No diagnosis of MS
- Not relapse-free for at least 30 days
- Not able to walk with or without an assistive device
- Too much physical activity (i.e. 150 minutes or more of moderate to vigorous physical activity per week)
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 |
|---|---|---|
| Exercise Training ProgramThe intervention group will be encouraged to complete aerobic and resistance training exercises three times a week, and either at home, in the community (e.g., park, shopping mall), or any suitable environment of the participant's choice. Exercise equipment for monitoring walking and complete resistance training will be provided to the intervention group. The exercise training prescription involves 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and resistance training consisting of 1-2 sets, 10-15 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands. | Behavioural | Exercise Training Program |
| Flexibility ProgramThe control group will be encouraged to complete stretching and range of motion exercises three times a week, and either at home, in the community (e.g., park, shopping mall), or any suitable environment of the participant's choice. Exercise equipment (yoga mat) for monitoring walking and complete flexibility training will be provided to the control group. The flexibility training prescription involves stretches from the Stretching for People with MS: An Illustrated Manual from the National MS Society. | Behavioural | Flexibility Program |
Primary outcome
Process: Participant Recruitment and Retention
Time frame: Before, During, and After 16 weeks, pre-, intra- and post-Intervention
Participant retention during the 16-week intervention period, reported as number of randomized participants who completed or did not complete the assigned program by study arm.
7 secondary outcomes
Lower Extremity Function
Time frame: Post-intervention at 16 weeks
Visual Processing Speed
Time frame: Post-intervention at 16 weeks
Verbal Learning and Memory
Time frame: Post-intervention at 16 weeks
Fatigue Severity
Time frame: Post-intervention at 16 weeks
Depression and Anxiety Symptoms
Time frame: Post-intervention at 16 weeks
Exercise Behavior
Time frame: Post-intervention at 16 weeks
Health-related Quality of Life
Time frame: Post-intervention at 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42112098Flores VA, Silveira SL, Marquez DX, Kinnett-Hopkins D, Miravalle A, Sierra-Morales F, Motl RW. Feasibility and preliminary outcomes of a remotely-delivered exercise training intervention for English-speaking Hispanics/Latinos with multiple sclerosis: Results from the FERLA MS study. Mult Scler J Exp Transl Clin. 2026 Apr 30;12(2):20552173261448001. doi: 10.1177/20552173261448001. eCollection 2026 Apr-Jun.
- Derived from this study: PubMed 40340698Flores VA, Silveira SL, Marquez DX, Kinnett-Hopkins D, Miravalle A, Sierra-Morales F, Hernandez-Peraza Z, Motl RW. Rationale for a 4-month, parallel-group, randomized controlled trial to assess the Feasibility and Efficacy of a Remotely delivered exercise training intervention for Hispanics/Latinos with Multiple Sclerosis (FERLA MS). Pilot Feasibility Stud. 2025 May 8;11(1):62. doi: 10.1186/s40814-025-01641-5.
- 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.
Robert Motl, Ph.D 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 Exercise Training Program and Flexibility 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 7 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Process: Participant Recruitment and Retention (time frame: Before, During, and After 16 weeks, pre-, intra- and post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998616, which also lists 2 linked publications.
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 7 Aug 2026.