Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early...

Area of Science:

• Neurology
• Rehabilitation Medicine
• Clinical Trials

Background:

• Relapsing-remitting multiple sclerosis (MS) requires strategies beyond medication to reduce relapses and neurodegeneration.
• Early intervention is key, yet a specific 'window of opportunity' for supplemental treatments in early MS exists.
• Exercise shows promise as a supplemental strategy for managing MS progression.

Purpose of the Study:

• To evaluate the efficacy of supervised high-intensity exercise as an early supplementary treatment for relapsing-remitting multiple sclerosis (MS).
• To assess the impact of exercise on disease activity, neurodegeneration, and functional outcomes in early MS.
• To explore exercise as a viable strategy to complement standard medical treatments in early MS.

Main Methods:

• A 48-week, national, multicentre, single-blinded, randomized controlled trial (RCT) comparing usual care plus high-intensity exercise versus usual care plus health education (active control).
• Primary outcomes include annual relapse rate and MRI-derived global brain atrophy.
• Secondary outcomes encompass disability progression, physical and cognitive function, MS symptoms, and exploratory MRI metrics. Intention-to-treat analyses will be employed.

Main Results:

• This section is to be filled once the study results are available.

Conclusions:

• This section is to be filled once the study results are available.