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Exercise in Progressive Multiple Sclerosis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29122
Enrollment
60
Registered
2020-01-06
Start date
2020-04-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Interventions

Progressive Resistance Training and High Intensity Interval training

Sponsors

Amsterdam UMC, location VUmc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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. o No history of heart problems o No symptoms that might indicate heart problems o No 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 o No metal inside the body o Not claustrophobic o No pregnancy

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Percentage brain volume change, a measure of brain atrophy to determine neurodegeneration

Secondary

MeasureTime frame
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))

Contacts

Public ContactArianne Gravesteijn

Amsterdam UMC, location VUmc

a.gravesteijn@amsterdamumc.nl020-44 44925

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)