Effect of High Intensity Training on Motor and Cognitive Functions

NCT ID: NCT06219304

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multimodal functional training

Multimodal training to reduce fatigue and to improve balance and strength

Group Type: EXPERIMENTAL

Multimodal functional training

Intervention Type: 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

Rehabilitative intervention to improve balance and mobility

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Exercises aimed at improving balance and mobility

Interventions

Multimodal functional training

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.

Intervention Type: OTHER

Usual care

Exercises aimed at improving balance and mobility

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ente Ospedaliero Ospedali Galliera

OTHER

Sponsor Role: collaborator

Fondazione Italiana Sclerosi Multipla

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione IRCCS Don Carlo Gnocchi

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elisa Gervasoni, Phd

Role: CONTACT

egervasoni@dongnocchi.it

3334534540 ext. 0039

Facility Contacts

Elisa Gervasoni, Phd

Role: primary

egervasoni@dongnocchi.it

3334534540 ext. 0039

Other Identifiers

FISM_FAST

Identifier Type: -

Identifier Source: org_study_id