The Feasibility and Efficacy of a Remotely Delivered Exercise Training Intervention for the Hispanic/Latino Community With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Resources: Communication and Monetary Requirements of the Study
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Exercise Training Program
Participants will receive a theory-based, remotely-delivered exercise training program that includes aerobic and resistance exercise training.
Intervention: Exercise Training Program (Behavioral)
Flexibility Program
Participants will receive a remotely-delivered flexibility program, focusing on improving flexibility and range of motion.
Intervention: Flexibility Program (Behavioral)
Outcomes
Primary Outcomes
Resources: Communication and Monetary Requirements of the Study
Time Frame: Before, During, and After 16 weeks, pre-, intra- and post-Intervention
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.
Management: Data Management and Safety Reporting During the Study
Time Frame: During and After 16 weeks, intra- and post-Intervention
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.
Scientific: Safety, Burden and Treatment Effect of the Study
Time Frame: During and After 16 weeks, intra- and post-Intervention
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.
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.
Secondary Outcomes
- Lower Extremity Function(Before and after 16 weeks, baseline and post-intervention)
- Visual Processing Speed(Before and after 16 weeks, baseline and post-intervention)
- Depressive Symptoms(Before and after 16 weeks, baseline and post-intervention)
- Exercise Behavior(Before and after 16 weeks, baseline and post-intervention)
- Verbal Learning and Memory(Before and after 16 weeks, baseline and post-intervention)
- Fatigue Severity(Before and after 16 weeks, baseline and post-intervention)
- Health-related Quality of Life(Before and after 16 weeks, baseline and post-intervention)
- Lower Extremity Function(Post-intervention at 16 weeks)
- Visual Processing Speed(Post-intervention at 16 weeks)
- Verbal Learning and Memory(Post-intervention at 16 weeks)
- Fatigue Severity(Post-intervention at 16 weeks)
- Depression and Anxiety Symptoms(Post-intervention at 16 weeks)
- Exercise Behavior(Post-intervention at 16 weeks)
- Health-related Quality of Life(Post-intervention at 16 weeks)
Investigators
Robert W Motl
Professor
University of Illinois at Chicago