Clinical trial NCT06219304: Effect of High Intensity Training on Motor and Cognitive Functions
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: fatigue
balance
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Ente Ospedaliero Ospedali Galliera
name: Fondazione Italiana Sclerosi Multipla
First posted: 2024-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: difference in walking velocity during the fatiguing walking test
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Secondary outcomes:
measure: gait asymmetry and gait regularity
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Antero-posterior and medio-lateral accelerations in stabilometric tasks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS)
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Other outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Multiple Sclerosis Walking Scale-12 (MSWS-12)
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Activities Balance Confidence Scale (ABC)
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Beck Depression Inventory (BDI-II).
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Don Carlo Gnocchi
state: MI
Study officials:
References: