Multiple Sclerosis
Conditions
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
Brief 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 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.
Interventions
BEHAVIORALExercise Training Program
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.
BEHAVIORALFlexibility Program
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.
Sponsors
University of Illinois at Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and outcomes assessors will be blinded to participant group assignment (exercise intervention or flexibility control group). However, it is important to note that due to the nature of the intervention, participants and outcomes assessors will be aware of the type of intervention received (aerobic/resistance training exercise or flexibility exercises). This is because the exercise intervention and flexibility control involve different activities. Randomization will be conducted by the investigator, who will not be involved in consent, delivery intervention, data collection, and outcome assessment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Process: Participant Recruitment and Retention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Function | Post-intervention at 16 weeks | 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. |
| Visual Processing Speed | Post-intervention at 16 weeks | 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. |
| Verbal Learning and Memory | Post-intervention at 16 weeks | 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. |
| Fatigue Severity | Post-intervention at 16 weeks | 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. |
| Depression and Anxiety Symptoms | Post-intervention at 16 weeks | 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. |
| Exercise Behavior | Post-intervention at 16 weeks | 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. |
| Health-related Quality of Life | Post-intervention at 16 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Motl, Ph.D
University of Illinois at Chicago
Participant flow
Recruitment details
A total of 340 individuals were contacted between March 2024 and February 2025 through university outreach, community events, and advertisements. Of these, 112 were eligible (33%). Thirty-three participants consented and enrolled; however, the study was terminated early due to NIH funding withdrawal prior to reaching the planned sample size (N=50).
Pre-assignment details
Three participants withdrew prior to randomization. Thirty participants were randomized (1:1) to the exercise intervention or flexibility control condition.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 11.6 |
| Disease duration | 7.4 years STANDARD_DEVIATION 6.1 |
| Disease-modifying therapy use No | 5 Participants |
| Disease-modifying therapy use Yes | 11 Participants |
| MS Type Primary Progressive MS | 2 Participants |
| MS Type RRMS | 22 Participants |
| MS Type Secondary Progressive MS | 1 Participants |
| Multiple Sclerosis Walking Scale-12 (MSWS-12) | 38.4 points STANDARD_DEVIATION 29.6 |
| Patient-Determined Disease Steps (PDDS) Bilateral | 2 Participants |
| Patient-Determined Disease Steps (PDDS) Early Cane | 0 Participants |
| Patient-Determined Disease Steps (PDDS) Gait | 4 Participants |
| Patient-Determined Disease Steps (PDDS) Mild | 4 Participants |
| Patient-Determined Disease Steps (PDDS) Moderate | 2 Participants |
| Patient-Determined Disease Steps (PDDS) Normal | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 26 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 2 Participants |
| Years of education | 15.7 years STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
None listed