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Exercise and Brain Health in MS

4 maart 2021 bijgewerkt door: McMaster University

Exercise and Brain Health in Multiple Sclerosis: A Pilot Study

Physical activity is now recognized as a therapy for Multiple Sclerosis (MS) that not only improves physical fitness and functional mobility, but there is some evidence that it may also positively influence the more invisible symptoms of the disease that represent "brain health" - fatigue, depression and cognitive impairment. One important feature of physical activity is that it reduces inflammation throughout the body and the brain. The goal of this research is to determine whether people with MS feel less fatigue, depression and cognitive impairment after a program of exercise because there is a decrease in the state of inflammation in the brain.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Multiple Sclerosis (MS) is a chronic, degenerative disease of the central nervous system, characterized by inflammatory demyelination and axonal degeneration. MS affects approximately 1 in 500 Canadians. There is no cure for MS and the heterogeneous symptoms of the disease makes it difficult to prescribe effective treatment strategies for disease management. While the progression, severity and specific symptom profile vary from person to person, there are three key symptoms associated with brain health- fatigue, depression and cognitive impairment- that invariably lead to poor quality of life and increased health care costs. Unfortunately, the majority of people with MS suffer from these symptoms (fatigue affects ~90%, depression affects ~50% and cognitive impairment affects 40-65%) and a critical challenge with MS is that these symptoms do not present individually. For example, persons with MS who experience depression are more likely to also experience fatigue and/or cognitive impairment, which together may be more detrimental to quality of life than each symptom alone.

New evidence suggests that the three symptoms affecting brain health may be interrelated through a common mechanism of inflammation. Further, physical exercise is known to reduce inflammation and thus is a prime candidate for a novel therapeutic approach to symptom management through its effect on modulating the inflammatory response. Indeed, physical activity is already used to improve the physical status of individuals with MS and evidence-based physical activity guidelines (PAGs) for MS have been developed to guide prescription. However, the guidelines have not been tested for their effects on reducing inflammation and brain health disease systems. Therefore, the proposed research will be the first to evaluate the clinical utility of the PAGs for MS in reducing brain health disease symptoms and improving quality of life, and the first to comprehensively determine the putative effects of inflammation on these symptoms.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Physical Activity Centre for Excellence

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Diagnosis of Relapsing-Remitting MS (RRMS) with mild-moderate disability (EDSS 2-5)
  • Aged 18-60
  • Score of ≥ 10 on MFIS-5*
  • Medical clearance to participate in physical activity * The MFIS-5 is an abbreviated version of the 21-item MFIS, consisting of 5 of the 21 items of the MFIS that most strongly correlate with the total MFIS score. A score ≥ 10 on the MFIS-5 is considered to indicate "high-level" of fatigue

Exclusion Criteria:

  • Current participation in regular physical activity (at least twice-weekly)
  • Other serious medical condition that might impair ability to participate in strength or aerobic exercise

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Exercise
Participants will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS for 12 weeks at McMaster University. Following this, they will return to their normal daily activities for a further 12 weeks.
Ander: Twice-weekly exercise
An individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant.
Experimenteel: Wait-list Control
Participants will engage in their usual daily activities for the first 12 weeks of the study, then will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS at McMaster University for the 2nd 12 weeks.
Ander: Twice-weekly exercise
An individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Perceived Fatigue
Tijdsspanne: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Changes in perceived fatigue as a result of the intervention will be assessed through changes in scores on the Modified Fatigue Impact Scale (MFIS-21).
Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in Inflammatory Markers
Tijdsspanne: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Inflammatory markers will be measured from the blood. Participants will have 15ml of blood drawn by a trained phlebotomist. Levels of serum cytokines (TNF, IL6, IL10, IL1RA) will be measured in using the custom created Milliplex MAP Human Magnetic Bead Panel (Millipore, ON, CA). Cellular immunophenotyping will be performed to test whether there are changes in cellular inflammation.
Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in Depression
Tijdsspanne: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in depression will be measured with the Hospital Anxiety and Depression Scale (HADS).
Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in Cognition
Tijdsspanne: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Changes in cognitive ability will be assessed by using the Brief International Cognitive Assessment for MS (BICAMS) test battery.
Outcome will be measured at Baseline, 12 weeks and 24 weeks.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Aerobic Capacity
Tijdsspanne: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Participants will perform a progressive exercise test on the cycle ergometer to determine peak oxygen consumption (aerobic capacity). Expired gas and ventilatory parameters will be acquired throughout the protocol using a metabolic cart allowing for the determination of submaximal and maximal oxygen consumption.
Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Change in Muscle Strength
Tijdsspanne: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
The maximum weight that can be lifted in one repetition (1RM) will be assessed in major muscle groups of the upper and lower body to assess muscle strength.
Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Change in Perceived Quality of Life (QOL)
Tijdsspanne: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Health-related quality of life will be assessed by the disease-specific MS Quality of Life-54 (MSQoL-54) questionnaire.
Outcomes will be measured at Baseline, 12 weeks and 24 weeks.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

McMaster University

Medewerkers

National Multiple Sclerosis Society

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2018

Primaire voltooiing (Werkelijk)

30 juni 2019

Studie voltooiing (Werkelijk)

1 september 2019

Studieregistratiedata

Eerst ingediend

2 augustus 2018

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2018

Eerst geplaatst (Werkelijk)

20 augustus 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 maart 2021

Laatste update ingediend die voldeed aan QC-criteria

4 maart 2021

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RG-1707-28348

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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