The Effect of Exercise on Peripheral Blood Gene Expression in Angina
13. april 2016 opdateret af: Sheffield Teaching Hospitals NHS Foundation Trust
A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.
We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Yorkshire
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Sheffield, South Yorkshire, Det Forenede Kongerige, S5 7AU
- NIHR Cardiovascular Biomedical Research Unit
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Class I to III angina pectoris (classified according to the Canadian Cardiovascular Society [CCS])with documented myocardial ischemia or coronary artery disease on angiography
- Ability to read and speak English to a level allowing satisfactory completion of written questionnaires and to understand instruction during the exercise programme.
Exclusion Criteria:
- Acute coronary syndromes or recent myocardial infarction (<2 months)
- Left main coronary artery stenosis >25% or high-grade proximal left anterior descending artery stenosis
- Known reduced left ventricular function (ejection fraction <40%)
- Significant valvular heart disease
- Insulin-dependent diabetes mellitus
- Occupational, orthopedic, and other conditions that preclude regular exercise
- Patients whose ECG prevents interpretation of an exercise test (LBBB, RBBB, pacemaker implantation).
- Patients who already perform greater than 30min continuous exercise three times weekly (self-reported).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 12 week exercise training
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randomised to 12 weeks of exercise training up to three times weekly.
Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.
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Ingen indgriben: Conventional Care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Peripheral blood gene expression
Tidsramme: baseline
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baseline
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Peripheral blood gene expression
Tidsramme: 6wks after starting 12week exercise training (or conventional care)
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6wks after starting 12week exercise training (or conventional care)
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peripheral blood gene expression
Tidsramme: 12 weeks after exercise training (or conventional care)
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12 weeks after exercise training (or conventional care)
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Peripheral blood gene expression
Tidsramme: 24 weeks after starting 12 weeks exercise training programme
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24 weeks after starting 12 weeks exercise training programme
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Angina status
Tidsramme: baseline
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baseline
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Angina status
Tidsramme: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Angina status
Tidsramme: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Angina Status
Tidsramme: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
Tidsramme: baseline
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baseline
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Anxiety Score
Tidsramme: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
Tidsramme: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
Tidsramme: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Depression Score
Tidsramme: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Depression Score
Tidsramme: baseline
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baseline
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Depression Score
Tidsramme: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Depression Score
Tidsramme: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2010
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
18. juni 2010
Først indsendt, der opfyldte QC-kriterier
18. juni 2010
Først opslået (Skøn)
22. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STH15565
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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