Clinical trial NCT05998616: Feasibility of Remote Exercise Training for Hispanics/Latinos With MS
Official title: The Feasibility and Efficacy of a Remotely Delivered Exercise Training Intervention for the Hispanic/Latino Community With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
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
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-08-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Process: Participant Recruitment and Retention
timeFrame: Before, During, and After 16 weeks, pre-, intra- and post-Intervention
measure: Resources: Communication and Monetary Requirements of the Study
timeFrame: Before, During, and After 16 weeks, pre-, intra- and post-Intervention
measure: Management: Data Management and Safety Reporting During the Study
timeFrame: During and After 16 weeks, intra- and post-Intervention
measure: Scientific: Safety, Burden and Treatment Effect of the Study
timeFrame: During and After 16 weeks, intra- and post-Intervention
Secondary outcomes:
measure: Lower Extremity Function
timeFrame: Before and after 16 weeks, baseline and post-intervention
measure: Visual Processing Speed
timeFrame: Before and after 16 weeks, baseline and post-intervention
measure: Verbal Learning and Memory
timeFrame: Before and after 16 weeks, baseline and post-intervention
measure: Fatigue Severity
timeFrame: Before and after 16 weeks, baseline and post-intervention
measure: Depressive Symptoms
timeFrame: Before and after 16 weeks, baseline and post-intervention
measure: Exercise Behavior
timeFrame: Before and after 16 weeks, baseline and post-intervention
measure: Health-related Quality of Life
timeFrame: Before and after 16 weeks, baseline and post-intervention
Other outcomes:
measure: Social Determinants of Health Factors
timeFrame: Before and after 16 weeks, baseline and post-intervention
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Robert Motl, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: