Exercise in Progressive Multiple Sclerosis
- Conditions
- <p>Multiple Sclerosis</p>
- Registration Number
- NL-OMON29122
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
PMS 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.
oNo history of heart problems
oNo symptoms that might indicate heart problems
oNo other major health issues
Age between 18 and 60 years old
Able to understand therapists instructions
Fulfilling the safety criteria for magnetic resonance (MR) assessment
oNo metal inside the body
oNot claustrophobic
oNo pregnancy
Diagnosed with PPMS
Relapse within 3 months of baseline visit
Severe comorbidity (Cumulative Illness Rating Scale (CIRS) = 3 on 1 or more organ systems).
Initiation of Fampridine within 6 months of baseline visit.
Depression, Hospital Anxiety and Depression Scale (HADS) 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>Percentage brain volume change, a measure of brain atrophy to determine neurodegeneration</p>
- Secondary Outcome Measures
Name Time Method <p>Neurodegeneration: - White matter microstructural integrity - lesion load - regional atrophy - functional connectivity - Brain derived neurotrophic factors - Serum neurofilament light - Immune cell profiles Disability: - Expanded disability status scale - Cardiorespiratory fitness (VO2peak) - Muscle strength (1-RM) - Cognition (Brief Cognitive Assessment for Multiple Sclerosis) - 25 foot timed walked test - Energy cost of walking - Balance (Berg Balance Scale) - Depression (Hospital Anxiety and Depression Scale) - Disease impact (Multiple Sclerosis Impact Scale) - Fatigue (Checklist Individual Strength) - Health related quality of life (SF-36) - Walking ability (Multiple Sclerosis Walking Scale) - Exercise self-efficacy (Exercise Self-Efficacy Scale) - Stress resilience (Connor Davison Resilience Scale) Cardiovascular risk profile - Anthropometrics (height, weight, % body fat) - Blood pressure - Cardiovascular risk profile in blood (lipid-profiles, CRP, Glucose (HbA1c))</p>