High intensity training's effects on motor and cognitive functions in MS patients
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
This study tests if high intensity training can help people with Multiple Sclerosis improve their walking, balance, and thinking skills while managing fatigue better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06219304 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of high intensity functional training on motor and cognitive functions in individuals with Multiple Sclerosis (MS). It aims to assess how reducing fatigability through structured training can influence walking, balance, and cognitive performance, utilizing advanced wearable devices for objective measurement. Participants will undergo multimodal functional training compared to usual care, with a focus on understanding the relationship between fatigue and performance in dual task scenarios. The study seeks to fill gaps in current knowledge regarding the effects of fatigability on MS patients' daily functioning.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a clinical diagnosis of stable Multiple Sclerosis and an EDSS score between 1.5 and 6.
Not a fit: Patients experiencing an MS relapse, severe joint disorders, or other neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for enhancing mobility and cognitive function in MS patients.
How similar studies have performed: Previous studies have shown promising results with high intensity training in MS, but this specific approach focusing on fatigability and dual tasks is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, MI
- Fondazione IRCCS Don Carlo Gnocchi — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Elisa Gervasoni, Phd
- Email: egervasoni@dongnocchi.it
- Phone: 3334534540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.