We hypothesize that both progressive resistance training and high intensity interval training positively affect the primary outcome measure ( i.e. no change in percentage brain volume change). In addition, we expect positive effects on the secondary…
ID
Source
Brief title
Health condition
Multiple Sclerosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage brain volume change, a measure of brain atrophy to determine neurodegeneration
Secondary outcome
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))
Background summary
Currently there are no disease modifying treatment options for people with progressive multiple sclerosis. Neurodegeneration rather than inflammation, seems to play a key role in the progressive phase of MS. Evidence from animal models, healthy aging individuals and people with multiple sclerosis suggests that exercise (e.g. resistance training and endurance training) might be a possible therapy affecting neurodegeneration. The primary aim of this trail is to assess whether two types of exercise programs can slow down neurodegeneration in progressive multiple sclerosis. In addition, we want to examine the effects of these interventions on disability and on the cardiovascular risk profile. In this extended baseline randomized clinical trial, participants are their own control group.
Study objective
We hypothesize that both progressive resistance training and high intensity interval training positively affect the primary outcome measure ( i.e. no change in percentage brain volume change). In addition, we expect positive effects on the secondary outcomes measures for disability and the cardiovascular risk profile. Also, we will exploratory evaluate the effect sizes for the different interventions for future research.
Study design
baseline (week 1), extended baseline (week 16), post-intervention (week 33),16-week follow-up (week 48)
Intervention
Progressive Resistance Training and High Intensity Interval training
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8265 |
| CCMO | NL71762.029.19 |
| OMON | NL-OMON55151 |