Feasibility of Remote Exercise Training for Hispanics/Latinos With MS

NCT05998616 | Completed

• 2 other identifiers: Study2023-0665P50MD017349
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• Lower Extremity Function

  Before and after 16 weeks, baseline and post-intervention

• Visual Processing Speed

  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

• Depressive Symptoms

  Before and after 16 weeks, baseline and post-intervention

Other Outcomes (1)

• Social Determinants of Health Factors

  Before and after 16 weeks, baseline and post-intervention

Study Arms (2)

Exercise Training Program

EXPERIMENTAL

Participants will receive a theory-based, remotely-delivered exercise training program that includes aerobic and resistance exercise training.

Behavioral: Exercise Training Program

Flexibility Program

ACTIVE COMPARATOR

Participants will receive a remotely-delivered flexibility program, focusing on improving flexibility and range of motion.

Behavioral: Flexibility Program

Interventions

Exercise Training Program BEHAVIORAL

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.

Exercise Training Program

Flexibility Program BEHAVIORAL

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.

Flexibility Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Flores 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.

  PMID: 40340698 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Motl, Ph.D

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 21, 2023
• Study Start: April 27, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)