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Can intense exercise help MS patients walk and think through fatigue?

NCT ID NCT06219304

Symptom relief Sponsor: Fondazione Don Carlo Gnocchi ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Fatigue is one of the most common problems in multiple sclerosis, and it can make walking, balance, and thinking harder. Researchers want to measure how fatigue changes these functions during a long walking test using wearable sensors. They are also testing whether a high-intensity training program that combines treadmill walking, balance work, and strength exercises can improve movement and thinking in people with MS. The pilot study enrolls 30 adults with stable MS who can stand and walk without help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-intensity multimodal functional training, a program combining treadmill walking, balance work, and strength exercises
What this could lead to
If it works, this could point toward a training program that helps people with MS walk more steadily and think more clearly when fatigue sets in.
What could go wrong
This is a small pilot study of 30 people, so any benefit may not hold up in larger trials. High-intensity exercise can also be tiring or uncomfortable for people with MS, and some participants may not finish the program.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * More than 18 years of age * Clinical diagnosis of Multiple Sclerosis (MS) * Stable disease course without worsening more than 1 EDSS point over the last 3 months, -EDSS between 1.5 and 6 points * Must be able to maintain upright posture without any assistance for 30 seconds * Must be able to release a written informed consent. Exclusion Criteria: * MS relapse within the previous three months; * Unable to comprehend the aims of the study and to follow test instructions; * Diagnosis of major depression (DSM-5); * Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment); * Cardiovascular diseases; * Unconfirmed or uncertain diagnosis of MS (McDonald criteria) * Other concomitant neurological disease; * Patients already performing aerobic or walking exercise.

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Conditions

The condition(s) this trial relates to.

Fatigue multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Fondazione IRCCS Don Carlo Gnocchi

    Milan, MI, 20148, Italy

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