europrotective Effects of Exercise in People with Progressive Multiple Sclerosis: a phase II trial

Phase 2

Completed

• Conditions: 10012303; Progressive Multiple Sclerosis; Progressive MS

• Registration Number: NL-OMON55151
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 59

Inclusion Criteria

Progressive Multiple Sclerosis diagnosis defined as: *definite diagnosis of MS
according to the 2017 McDonald Criteria with gradual progression of
neurological impairments according to the Lublin criteria 2013.*
EDSS Scale 3.5 - 6
Able to participate in the exercise programs, i.e. no contra-indications for
training according to the guidelines of the American college of Sports Medicine
- No history of heart problems
- No symptoms that might indicate heart problems
- No other major health issues
Age between 18 and 70 years old
Able to understand therapists instructions
Fulfilling the safety criteria for magnetic resonance assessment
- No metal inside the body
- Not claustrophobic
- No pregnancy

Exclusion Criteria

Diagnosed with primary progressive multiple sclerosis
Relapse within 3 months of baseline visit
Severe comorbidity (Cumulative Illness Rating Scale >= 3 on 1 or more organ
systems).
Initiation of Fampridine within 6 months of baseline visit.
Depression, Hospital Anxiety and Depression Scale score, depression subscale
>=11 (i.e. indicative of clinical anxiety disorder or clinical depression)
Other neurological- and/or musculoskeletal disorders
Already participating in a (guided) high intensity exercise training
Participating in another intervention study
Pregnancy, given birth previous 6 months, or active pregnancy wish

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure of this study is neurodegeneration, primarily<br /><br>operationalized by brain atrophy on brain MRI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters will include disability parameters and<br /><br>cardiovascular risk profile. </p><br>