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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Multimodal functional training; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisa Gervasoni, Phd; Phone Number: 0039 3334534540; Email: egervasoni@dongnocchi.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20148
      • Recruiting
      • Fondazione IRCCS Don Carlo Gnocchi
      • Contact: Elisa Gervasoni, Phd; Phone Number: 0039 3334534540; Email: egervasoni@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal functional training; Multimodal training to reduce fatigue and to improve balance and strength	Other: 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.
Active Comparator: Usual care; Rehabilitative intervention to improve balance and mobility	Other: Usual care; Exercises aimed at improving balance and mobility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait asymmetry and gait regularity	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.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Antero-posterior and medio-lateral accelerations in stabilometric tasks	Antero-posterior and medio-lateral accelerations from the IMU placed on the pelvis during a 60 seconds tasks performed with open and closed eyes.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS)	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.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Fatigue Impact Scale (MFIS)	Assessment of fatigue with a 21-items questionnaire that ranges from 0 to 36 as maximum score.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Multiple Sclerosis Walking Scale-12 (MSWS-12)	Assessment of perceived walking ability with a 12-items questionnaire that ranges from a minimum of 12 points to a maximum of 60 points.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Activities Balance Confidence Scale (ABC)	Assessment of perceived balance with a 16-items questinnaire that ranges from a minimum of 0% to a maximum of 100%.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Beck Depression Inventory (BDI-II).	Assessment of mood and anxiety with a 21-items questionnaire that ranges from a minimum of 0 points to a maximum of 63 points	Baseline and at 6-8 weeks (after the completion of 16 training sessions)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Fondazione Italiana Sclerosi Multipla; Ente Ospedaliero Ospedali Galliera

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: fatigue; balance
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: FISM_FAST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No