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

NARecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

June 14, 2023

Primary Completion Date

March 1, 2024

Study Completion Date

March 1, 2026

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.

Trial Locations (1)

50143

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi ONLUS, Florence

All Listed Sponsors
collaborator

Careggi Hospital

OTHER

collaborator

Sheba Medical Center

OTHER_GOV

collaborator

Uppsala University

OTHER

lead

Fondazione Don Carlo Gnocchi Onlus

OTHER