Effect of High Intensity Training on Motor and Cognitive Functions
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal functional training
Other intervention40 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
Other interventionExercises aimed at improving balance and mobility
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Multimodal functional trainingExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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, \[m/s\]
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)Secondary outcomes
1
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.
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)2
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.
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)3
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.
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)Other outcomes
1
Modified Fatigue Impact Scale (MFIS)
Assessment of fatigue with a 21-items questionnaire that ranges from 0 to 36 as maximum score.
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)2
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.
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)3
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%.
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)4
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
Time frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Ente Ospedaliero Ospedali Galliera
Collaborator
Fondazione Italiana Sclerosi Multipla
Collaborator
Source ClinicalTrials.gov