Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2025-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study Significance: This proposed investigation is designed to examine the feasibility of an exercise-based intervention to reduce frailty in people living with MS. The proposed research will be the first to establish the feasibility of targeting frailty in pwMS and will begin to examine the dynamic nature of frailty in MS. These advances will pave the way for planned prospective studies toward effective targets for diagnostics, and rehabilitation of frailty in MS.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Home-based Balance Training in Adults With Multiple Sclerosis

NCT06412003

Multiple Sclerosis Multiple Sclerosis, MS

NOT_YET_RECRUITING NA

Effects of High-intensity Gait Training on Fatigue, Gait, and Neuroplasticity in People With Multiple Sclerosis

NCT06264336

Multiple Sclerosis

RECRUITING NA

Effect of High Intensity Training on Motor and Cognitive Functions

NCT06219304

Multiple Sclerosis

RECRUITING NA

Assistive Device Training in Multiple Sclerosis

NCT02408718

Multiple Sclerosis

COMPLETED NA

Dynamic Balance Training in Multiple Sclerosis

NCT04719494

Multiple Sclerosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Frailty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Participants randomized to the control group will be put on a waitlist (passive control group) for 6 weeks. Upon completion of post-training assessment, participants in the control group will be able to receive the intervention, if they wish so.

Group Type OTHER

Waitlist

Intervention Type OTHER

listed in arm/group description

Multimodal Exercise Group

Participants will complete 15 minutes of virtual reality treadmill training (VRTT), followed by 30 minutes of progressive evidence-based resistance training (RT), followed by other 15 minutes of VRTT.

Group Type EXPERIMENTAL

Multimodal Exercise Group

Intervention Type OTHER

Listed in arm/ group descriptions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multimodal Exercise Group

Listed in arm/ group descriptions

Intervention Type OTHER

Waitlist

listed in arm/group description

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects must be aged 40-65 years old to be enrolled in this study.
* Subjects must meet 3 of 5 frailty criteria (weight loss; exhaustion; weakness; slowness; inactivity) to be considered.
* Subjects must have a confirmed diagnosis of MS by the treating neurologist
* be free from MS relapses in the last 30 days
* have an Expanded Disability Status Scale (EDSS) score ≤ 6.0
* be fluent in spoken and written English.

Exclusion Criteria

* unable to walk unassisted for at least ten meters
* are diagnosed with other clinically important neurological conditions (such as Parkinson's Disease, epilepsy, etc.)
* exhibit severe cognitive impairment (as determined by a Mini-Cog score \<3)
* are diagnosed with active psychiatric problems.
* unstable cardiovascular conditions (e.g., malignant arrhythmias, critical mitral stenosis, clinically severe left ventricular outflow obstruction, critical proximal coronary artery stenosis)
* arthritis of the lower limbs
* acute lower back or lower limbs pain
* rheumatic and/or severe orthopedic problems that may interfere with resistance training.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No