Status:
RECRUITING
Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Universiteit Leiden
Personal Fitness Nederland
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-67 years
Phase:
NA
Brief Summary
The goal of this randomized controlled trial is to compare the effectiveness of two innovative interventions aimed at preventing cognitive decline and work-related problems to enhanced usual care in i...
Detailed Description
Background Up to 65% of the people with multiple sclerosis (PwMS) develop cognitive deficits that severely affect daily life functioning and PwMS' quality of life. Moreover, approximately 65% of all p...
Eligibility Criteria
Inclusion
- Confirmed MS diagnosis according to the McDonald 2017 criteria
- Age between 18 and 67
- No changes in disease modifying therapy prior to inclusion (i.e., no changes in last 3 months) - this criterion only applies at inclusion to ensure participants are in a stable situation at the start of the study and for follow-up measures, changes in treatment will be registered but will not result in exclusion from the study
- no current relapse or steroid treatment in the six weeks prior to study visits
- presence of mild cognitive deficits (at least one test with a Z-score of -1.0 to -1.99 below norm scores of healthy controls on the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery
- being able to participate in an exercise intervention (i.e., EDSS \< 6.0)
- fulfilling safety criteria for MRI (no metal inside body, not pregnant, no claustrophobia)
Exclusion
- presence of neurological (other than MS) and psychiatric disorders
- a current or history of drug or alcohol abuse
- being unable to speak or read Dutch
- currently on sick leave for a period of 6 weeks or longer
- currently pregnant
Key Trial Info
Start Date :
April 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06068582
Start Date
April 16 2023
End Date
September 1 2026
Last Update
April 3 2025
Active Locations (1)
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1
Amsterdam University Medical Centers, location VUmc
Amsterdam, Netherlands