Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis

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 improving quality of life in people with multiple sclerosis. Secondary objectives are:

* to compare the effectiveness of the investigated interventions in improving cognitive, psychological, and work functioning, and in enhancing the brain's functional network
* to examine which factors (i.e., baseline cognitive, psychological, work, and brain MRI-parameters) are predictive of the response to the investigated interventions
* aim to qualitatively reflect on the process and outcome of the investigated interventions considering the perspectives of relevant stakeholders to allow for smooth and successful implementation in clinical practice

Participants will follow the intervention for four months, with follow-up measurements at six months after intervention and 12 months after intervention.

Conditions

• Multiple Sclerosis

Interventions

BEHAVIORAL

Strenghtening the brain

Lifestyle intervention containing physical exercise, lifestyle coaching, and cognitive training. The programme contains weekly 30 minutes 1-on-1 fitness and lifestyle coaching with two moments of exercise at home for 20 minutes. Online computerized cognitive training will be done for 60 minutes per week.

BEHAVIORAL

Strengthening the mind

Work-focused intervention combining the capability approach and the participatory approach. Together with a work-coach who has been diagnosed with MS themselves, participants will assess important work values, discover challenges participants are facing, think of solutions for these challenges, develop a plan of action and implement these solutions.

Sponsors & Collaborators

• Universiteit Leiden

  collaborator OTHER

• Personal Fitness Nederland

  collaborator UNKNOWN

• MS Vereniging Nederland

  collaborator UNKNOWN

• Merck BV

  collaborator UNKNOWN

• Genzyme, a Sanofi Company

  collaborator INDUSTRY

• MS Sherpa

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Hanneke E Hulst · Leiden University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

67 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-16

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Netherlands

Study Locations