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NCT Number: NCT06219304

Effect of High Intensity Training on Motor and Cognitive Functions

Fatigability is one of the most prevalent disorder in MS followed by walking, balance and cognitive disorders.

However, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. Nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (Moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. So far, high intensity functional training has been already used in MS to reduce fatigability. However, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions.

Thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Don Carlo Gnocchi

Milan, MI, 20148, Italy

Location status: Recruiting

Location contact

Elisa Gervasoni, Phd

CONTACT

[email protected]

3334534540 ext. 0039

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal functional training

Other

40 minutes of multimodal functional training: 20 minutes of aerobic training on treadmill, 10 minutes of dynamic balance training; 10 minutes of functional strength training.

Usual Care

Other

Exercises aimed at improving balance and mobility

Primary outcomes

  1. difference in walking velocity during the fatiguing walking test

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    difference between velocity at the beginning of the test and velocity at the end of the fatiguability walking test, [m/s]

Secondary outcomes

  1. gait asymmetry and gait regularity

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    gait asymmetry, gait regularity on the vertical and medio-lateral plane estimated by autocorrelation coefficients during the fatiguability walking test. These variables will be calculated from IMU's data.

  2. Antero-posterior and medio-lateral accelerations in stabilometric tasks

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    Antero-posterior and medio-lateral accelerations from the IMU placed on the pelvis during a 60 seconds tasks performed with open and closed eyes.

  3. Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS)

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    BICAMS includes the Symbol Digit Modalities test (SDMT), the California Verbal Learning Test-2 (CVLT2) and the Brief Visuospatial Memory Test-Revised (BVMT-R).

    The total scores will be calculated considering the normative scores. The score on the oral SDMT varies from 0 to 110 and must be calculated with respect to years of schooling. The CVLT2 score varies from a minimum of 0 to a maximum of 16 points. The BVMT-R score ranges from a minimum of 0 to a maximum of 36 points.

Other outcomes

  1. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    Assessment of fatigue with a 21-items questionnaire that ranges from 0 to 36 as maximum score.

  2. Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    Assessment of perceived walking ability with a 12-items questionnaire that ranges from a minimum of 12 points to a maximum of 60 points.

  3. Activities Balance Confidence Scale (ABC)

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    Assessment of perceived balance with a 16-items questinnaire that ranges from a minimum of 0% to a maximum of 100%.

  4. Beck Depression Inventory (BDI-II).

    Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)

    Assessment of mood and anxiety with a 21-items questionnaire that ranges from a minimum of 0 points to a maximum of 63 points

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Gervasoni, Phd

CONTACT

[email protected]

3334534540 ext. 0039

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Ente Ospedaliero Ospedali Galliera
  • Fondazione Italiana Sclerosi Multipla

Registry information

Official study title

Evaluation of the Impact of Experimentally Induced Fatigability on Motor and Cognitive Functions. Effect of High Intensity Training on Motor and Cognitive Functions:a Pilot Randomized Controlled Trial

Acronym: FAST

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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