Effect of High Intensity Training on Motor and Cognitive Functions (FAST)

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Multimodal functional training; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06219304

FISM_FAST

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Multimodal functional training

Experimental group

Description:

Multimodal training to reduce fatigue and to improve balance and strength

Treatment:

Other: Multimodal functional training

Usual care

Active Comparator group

Description:

Rehabilitative intervention to improve balance and mobility

Treatment:

Other: Usual care