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Exercise program aims to boost both body and mind in multiple sclerosis

NCT ID NCT06341023

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial investigates a Functional Balance Intervention (FBI) — a structured exercise program — for people aged 55 to 80 with multiple sclerosis. The program includes agility, strength, balance, and dual-task exercises done twice a week for four months, either in a lab or at home. The goal is to see if it improves physical abilities like walking and balance, as well as cognitive functions like memory and attention. The study compares the FBI program to a stretching routine to measure any added benefits.

What this could mean

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

Active substance
Functional Balance Intervention (exercise program)
What this could lead to
If it works, this could provide a low-cost, safe exercise program to improve mobility, balance, and thinking skills in people with multiple sclerosis.
What could go wrong
This is an early-phase trial with a small sample size. The exercise program may not show significant benefits, and results may not apply to all people with MS.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

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 to 90 years

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: Telephone screening (for Study 1 and 2): * Age group: Adults between 55-80 years of age * Self-reported diagnosis of Multiple Sclerosis * Be on stable disease modifying therapy (DMT) for ≥6 months. * Has not received physical therapy or occupational therapy services for ≥6 months. * Able to stand up from a chair independently with or without use of handrails. * Score between 25-75% on the 12-item Multiple Sclerosis walking scale, which indicates that they have mobility disability or walking dysfunction. * Absence of any other acute or chronic neurological (Stroke, Parkinson's disease), cardiopulmonary, musculoskeletal (injuries like fractures or dislocations or pathologies like Rheumatoid arthritis) or systemic diagnosis, all conditions that except Multiple Sclerosis that can directly impact individual's ability to stand and walk. * Can understand and communicate in English because the protocol will only be delivered in English. * Be willing to complete all aspects of the study protocol (outcome assessments, 4-month training, accelerometer wear, etc.). * Individuals who give a positive response (Yes) to the question of whether the participants feel that their memory or thinking skills worsened lately?" will be marked as potential individuals with mild cognitive impairment. * Must be willing to come to the lab for 2 times a week for four months for training sessions (for Study 1 participants only). * Must have access to the internet and must be willing to attend weekly zoom calls and undergo monthly tests on zoom (for Study 2 participants only). * Must be living with a family member (for Study 2 participants only). * Must have a helper buddy to be present during the home exercise sessions and monthly progression evaluation Zoom calls with the researcher (for Study 2 participants only). In-person Screening (for Study 1 and 2): * Must have mobility Disability, a score of 4.0-6.5 on the Expanded Disability Status Scale (EDSS). * Must have mild cognitive impairment, a score of 18-25 on the Montreal Cognitive Assessment (MoCA) and score \>1 but less than 2.5 standard deviations on 2 or more measures within at least 1 domain (e.g., memory, language, attention/processing speed, executive function, visuospatial abilities) on the established criteria named "Jak / Bondi" criteria. * Must be physically inactive, a score \<14 on the questionnaire named "Godin leisure time" questionnaire. Exclusion Criteria: Telephone Screening (for Study 1 and 2): * MS Relapse or exacerbation ≤3 months * Recent major surgery (\< 6 months) or hospitalization (\< 3 months) that might interfere with testing/training. * Complaints of shortness of breath or uncontrolled pain (\>3/10 on visual analogue scale (VAS)) at rest to avoid complications/injuries during testing/training. * Uncontrolled/untreated hypertension or diabetes to avoid cardiovascular complications during testing/training. * Self-reported history of bone fracture in the last six months to avoid complications/injuries during testing/training. * Self-reported disability in performing activities of daily living (with or without assistive device). * Self-reported diagnosis of epilepsy or uncontrolled seizures in the past year. * Intake of sedative drugs (diazepam, lorazepam, midazolam, propofol, dexmedetomidine, thiopental) that might interfere with testing/training. * Intake of any Alzheimer's Disease (AD) or dementia modifying medications (donepezil, rivastigmine, galantamine, aducanumab) as well as other anticipated FDA approved drugs that may be approved during the next 5 years. Individuals who are enrolled in any AD disease modifying drugs trials that might interfere with testing/training or affect the ability to understand instructions will also be excluded. * Intake of anti-depressants or anxiety drugs. * Moderate or high risk for possible injury or death when undertaking strenuous or maximal exercise as indicated by reporting a 'YES' on any of the seven items on the Physical Activity Readiness Questionnaire. These participants will be excluded from participation, and further advised to seek medical guidance from their physician. * People with severe cognitive impairment will be excluded, indicated by a score of 18 or higher on the Telephone Interview for Cognitive status (TICS-M). These participants will be advised to seek medical guidance from the physician. * Currently undergoing any cognitive rehabilitation for higher brain functions or physical rehabilitation. * Pacemaker users In-person Screening (for Study 1 and 2): * Cardiovascular abnormalities: Heart Rate \> 85% of age-predicted maximal heart rate, systolic blood pressure (SBP) \> 165 millimetre of mercury (mmHg), diastolic blood pressure \> 110 mmHg during rest OR systolic blood pressure \< 90 mmHg and/or mean arterial blood pressure \< 65 mmHg OR oxygen saturation \< 95% during rest. * Osteopenia (a T - Score of ≤-2.5 on heel ultrasound). Participants with a score ≤ -2.5 will be advised to seek medical guidance from their physician. * Loss of protective peripheral sensations (inability to perceive 5.07/10 g on the Semmes Monofilament testing). * Global aphasia (A score of \<71% on the Mississippi Aphasia Scoring test) * Peripheral nerve injuries (traumatic nerve lacerations, pathological nerve damage). * High fall-risk, \<40/56 on Berg Balance Scale (for Study 2 participants only) * Inability to walk 1 block with or without an assistive device (for Study 2 participants only)

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Conditions

The condition(s) this trial relates to.

multiple sclerosis Muscle Spasticity

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

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