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Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis

NCT06303024 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-03-12

No results posted yet for this study

Summary

Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

OTHER

personalized combined physical and cognitive intervention

The exercise intervention will be aerobic and performed on a stationary bicycle and will comply with the basic principle of progressive overload. An incremental exercise test until exhaustion on a bicycle ergometer will be applied to determine directly measured VO2-max in order to customize and personalize the training on each patient. The progressive aerobic exercise (PAE) will last 12 weeks with two sessions per week. Continuous training will be alternated with interval training during the program. The intervention included two weekly training sessions. One session will involve continuous exercise initially commencing at 10 min and progressing towards 30 min/session. Ultimately, a computer based cognitive rehabilitation program will be carried out twice a week for 12 weeks, using the Rehacom software. Participants will begin at level 1 on each RehaCom module and advance through the program as dictated by their performance. Each session will be programmed to last 60 minutes.

Sponsors & Collaborators

  • Careggi Hospital

    collaborator OTHER

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Uppsala University

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2024-03-01
Completion
2026-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303024 on ClinicalTrials.gov