Effect of High Intensity Training on Motor and Cognitive Functions

Multiple Sclerosis Clinical Trial

— FAST  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219304
• Other study ID #: FISM_FAST
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Elisa Gervasoni, Phd
• Phone: 3334534540
• Email: egervasoni[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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.
• Usual care
Exercises aimed at improving balance and mobility

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Don Carlo Gnocchi	Milan	MI

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Ente Ospedaliero Ospedali Galliera, Fondazione Italiana Sclerosi Multipla

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)