Effect of High Intensity Training on Motor and Cognitive Functions

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: Multimodal functional training; Other: Usual care

• Registration Number: NCT06219304
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal functional training	Multimodal functional training	Multimodal training to reduce fatigue and to improve balance and strength
Usual care	Usual care	Rehabilitative intervention to improve balance and mobility

Primary Outcome Measures

Name	Time	Method
difference in walking velocity during the fatiguing walking test	Baseline and at 6-8 weeks (after the completion of 16 training sessions)	difference between velocity at the beginning of the test and velocity at the end of the fatiguability walking test, \[m/s\]

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione IRCCS Don Carlo Gnocchi; 🇮🇹 Milan, MI, Italy