IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT05998616 (FERLAMS) para Esclerosis múltiple está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Universidad de Illinois en ChicagoFeasibility of Remote Exercise Training for Hispanics/Latinos With MS (FERLAMS)
- 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.
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.
The Feasibility and Efficacy of a Remotely Delivered Exercise Training Intervention for the Hispanic/Latino Community With Multiple Sclerosis
- FERLAMS
- Study2023-0665
- P50MD017349 (Subvención/contrato NIH (EE. UU.))
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
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalExercise Training Program Participants will receive a theory-based, remotely-delivered exercise training program that includes aerobic and resistance exercise training. | Programa de entrenamiento físico 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. |
Comparador activoFlexibility Program Participants will receive a remotely-delivered flexibility program, focusing on improving flexibility and range of motion. | Flexibility 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. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Process: Participant Recruitment and Retention | Assessed by recruitment and refusal rates, and retention, attrition, and adherence rates. This will be monitored and assessed with USPS, phone, and electronic mail recruitment, and record all contact with potential participants and refusal reasons. Participants' flow through recruitment, enrollment, and intervention will be monitored, and adherence will be assessed with log books, zoom assessments, and time spent in physical activity as measured during follow-up assessment. | Before, During, and After 16 weeks, pre-, intra- and post-Intervention |
Resources: Communication and Monetary Requirements of the Study | Assessed by communication with participants and staff (needs), and monetary costs of research. This will be monitored and assessed with data collected on initial and follow-up contact with all potential and enrolled participants. A record of all problems and communication alterations will be monitored, as well as all monetary costs for the study that includes both the intervention and control groups. | Before, During, and After 16 weeks, pre-, intra- and post-Intervention |
Management: Data Management and Safety Reporting During the Study | Assessed by IRB approval procedures, staff preparation and report time for participant communication, time and accuracy in data collection/entry, and reporting and handling of adverse events, serious adverse events, and clinical emergencies. All communications between University IRB and staff, and time from submission of IRB application to approval will be documented. All preparation, call time, attempted call time and report-taking time for each participant during the intervention will be documented. Data completeness, time to record completeness, time to record, enter, and check data will be monitored, and use and handling of all standard university protocol for reporting of all adverse events, serious adverse events, and clinical emergencies will be recorded. | During and After 16 weeks, intra- and post-Intervention |
Scientific: Safety, Burden and Treatment Effect of the Study | Assessed by adverse events, serious adverse events, and clinical emergencies, participants' experience, burden, and compliance during the intervention, and treatment effect. Standard university protocol to record all adverse events, serious adverse events, and clinical emergencies will be followed, and participants will be asked to report all medical concerns for staff to record via log books and zoom chats. Effect size and clinical meaningfulness of any change in physical activity, sedentary behavior, symptoms, and health-related quality of life outcomes will be measured. | During and After 16 weeks, intra- and post-Intervention |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Lower Extremity Function | Assessed by the 30-Second Sit to Stand Test (30STS). The score is the number of complete repetitions of sit-to-stand movements performed for 30 seconds; the minimum value is 0 repetitions, and the maximum value depends on individuals' performance. Higher scores reflect better lower extremity function. | Before and after 16 weeks, baseline and post-intervention |
Visual Processing Speed | Assessed by the Symbol Digit Modalities Test (SDMT). Participants will verbally identify digit-symbol pairings as quickly as possible in response to a series of unpaired symbols displayed on screen. The outcome is the total number of correct responses in 30, 60 and 90 seconds. | Before and after 16 weeks, baseline and post-intervention |
Verbal Learning and Memory | Assessed by the California Verbal Learning Test II (CVLT-II). Participants will be read aloud 16 words and immediately recall as many words as possible, in any order, for each of the five trials. The total score out of 80 will be calculated by summing the number of correct responses from each trial (T1 to T5). | Before and after 16 weeks, baseline and post-intervention |
Fatigue Severity | Assessed by the Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity. | Before and after 16 weeks, baseline and post-intervention |
Depressive Symptoms | Assessed by the Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms. | Before and after 16 weeks, baseline and post-intervention |
Exercise Behavior | Assessed by Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior. | Before and after 16 weeks, baseline and post-intervention |
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.The component scores are adjusted based on a relative average, where a score above 50 is considered above average and a score below 50 is considered below average. | Before and after 16 weeks, baseline and post-intervention |
- 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)
- 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
Universidad de Illinois en Chicago207 ensayos clínicos activos para explorarNational Institute on Minority Health and Health Disparities (NIMHD)Illinois