Effect of High Intensity Training on Motor and Cognitive Functions

NCT06219304 | Recruiting

• 1 other identifier: FISM_FAST
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

fatigue; balance

Outcome Measures

Primary Outcomes (1)

• difference in walking velocity during the fatiguing walking test

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

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

Secondary Outcomes (3)

• gait asymmetry and gait regularity

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

• Antero-posterior and medio-lateral accelerations in stabilometric tasks

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

• Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS)

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

Other Outcomes (4)

• Modified Fatigue Impact Scale (MFIS)

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

• Multiple Sclerosis Walking Scale-12 (MSWS-12)

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

• Activities Balance Confidence Scale (ABC)

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

Study Arms (2)

Multimodal functional training

EXPERIMENTAL

Multimodal training to reduce fatigue and to improve balance and strength

Other: Multimodal functional training

Usual care

ACTIVE COMPARATOR

Rehabilitative intervention to improve balance and mobility

Other: Usual care

Interventions

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.

Multimodal functional training

Usual care OTHER

Exercises aimed at improving balance and mobility

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Ente Ospedaliero Ospedali Galliera: collaborator
• Fondazione Italiana Sclerosi Multipla: collaborator

Study Sites (1)

Fondazione IRCCS Don Carlo Gnocchi

Milan, MI, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elisa Gervasoni, Phd

CONTACT

3334534540; egervasoni@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: January 23, 2024
• Study Start: September 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

IT (1)