What side effects are associated with this type of intervention?

Exercise-based treatments for Multiple Sclerosis, such as flexibility, aerobic, and resistance exercises, are generally well-tolerated and have few side effects. However, some individuals may experience temporary muscle soreness, fatigue, or increased spasticity. It is important for patients to start with low-intensity exercises and gradually increase the intensity to avoid overexertion. Other common treatments for MS, such as disease-modifying therapies, can have side effects including flu-like symptoms, injection site reactions, and more serious risks like liver damage or infections. Patients should work closely with their healthcare providers to manage any side effects and adjust treatment plans as needed.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies (DMTs) for the treatment of Multiple Sclerosis (MS), including oral formulations like dimethyl fumarate (BG-12), which has been shown to reduce relapse rates and the development of new brain lesions. Other approved DMTs include subcutaneous glatiramer acetate and various forms of interferon-beta. These treatments aim to manage symptoms and slow disease progression. Additionally, non-pharmacological interventions such as remotely-delivered exercise programs focusing on flexibility, aerobic, and resistance exercises have been studied for their potential to improve physical function, symptom management, and quality of life in MS patients.

What other types of research exist?

Promising, novel alternatives to a remotely-delivered exercise training program for MS patients in 2024 include: 1) High-Intensity Interval Training (HIIT) which has shown benefits in improving cardiovascular health and muscle strength. 2) Virtual Reality (VR)-based rehabilitation programs that provide immersive environments for physical therapy. 3) Neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS) to enhance motor function and reduce fatigue. 4) Advanced robotic-assisted therapy for precise and repetitive movement training. 5) Personalized telehealth platforms that integrate AI to tailor exercise and rehabilitation programs based on individual patient data.

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Behavioral Intervention

Remote Exercise Training for Multiple Sclerosis (FERLAMS Trial)

N/A

Recruiting

Led By Robert Motl, Ph.D

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after 16 weeks, baseline and post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates a home-based exercise program for Hispanics/Latinos with multiple sclerosis (MS). The program includes flexibility, aerobic, and resistance exercises guided by experienced coaches. It aims to improve physical function, manage symptoms, and enhance quality of life for this underserved group. The study also examines how factors like income and access to healthcare affect the program's success.

Who is the study for?

This trial is for Hispanic/Latino individuals aged 18-65 living in Chicago with MS, who are not currently very active. They must be relapse-free for at least a month, able to walk (with or without help), have internet access, and be safe to exercise.

What is being tested?

The study tests if a remote 4-month exercise program can improve physical function and quality of life in Hispanics/Latinos with MS. It includes flexibility and aerobic/resistance training guided by coaches compared to a control group.

What are the potential side effects?

Since this is an exercise-based intervention, potential side effects may include muscle soreness, fatigue, or injury related to physical activity. The risk is minimized by ensuring participants are cleared as safe for exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before, during, and after 16 weeks, pre-, intra- and post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before, during, and after 16 weeks, pre-, intra- and post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and before, during, and after 16 weeks, pre-, intra- and post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Management: Data Management and Safety Reporting During the Study

Process: Participant Recruitment and Retention

Resources: Communication and Monetary Requirements of the Study

+1 more

Secondary study objectives

Depressive Symptoms

Exercise Behavior

Fatigue Severity

+4 more

Other study objectives

Social Determinants of Health Factors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise Training ProgramExperimental Treatment1 Intervention

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

Group II: Flexibility ProgramActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Training Program

2019

N/A

~200

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exercise therapy, including flexibility, aerobic, and resistance training, improves physical function, symptom management, and quality of life in Multiple Sclerosis (MS) patients by reducing inflammation, promoting neuroplasticity, enhancing muscle strength, and improving cardiovascular health. These mechanisms are vital as they help mitigate the physical and cognitive decline associated with MS, thereby enhancing overall well-being and daily functioning.

Retention of Physical Gains in the Community Following Physical Training for Multiple Sclerosis: A Systematic Review and Implications.