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…
Bron
Verkorte titel
Aandoening
Multiple Sclerosis
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Percentage brain volume change, a measure of brain atrophy to determine neurodegeneration
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
baseline (week 1), extended baseline (week 16), post-intervention (week 33),16-week follow-up (week 48)
Onderzoeksproduct en/of interventie
Progressive Resistance Training and High Intensity Interval training
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL8265 |
CCMO | NL71762.029.19 |