- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02875522
The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
17. august 2016 oppdatert av: University of British Columbia
The Effects of Aerobic Exercise Training on Peripheral Vascular, Cardiac and Cerebral Vascular Function in Patients With Chronic Obstructive Pulmonary Disease
The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease.
Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD.
The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Chronic obstructive pulmonary disease (COPD) is a treatable respiratory condition that is only partially reversible.
The primary cause of COPD is smoking which leads to airway inflammation and oxidative damage to the lungs, which has been linked to the development and progression of the disease.
The inflammation is not isolated to the lungs as patients with COPD also have systemic inflammation that has been linked to a number of cardiovascular comorbidities such as endothelial dysfunction, cardiovascular disease and stroke.
Evidence demonstrates that COPD patients have a greater incidence of vascular dysfunction and adverse vascular remodeling, which worsens with disease severity.
In fact, patients with COPD are at 35 times greater risk of developing cardiovascular disease and stroke than healthy aged matched individuals.
In healthy individuals and a number of chronic conditions, aerobic exercise training is well established to reduce the risk of cardiovascular and cerebrovascular disease.
The benefits of exercise are likely through improvements in endothelial function, systemic inflammation, and cardiac and cerebral vascular function.
However, whether exercise training can have the same effects in a chronic inflammatory condition like COPD has not been studied.
The purpose of this study is to determine the effectiveness of an 8 week aerobic exercise training program in patient's chronic obstructive pulmonary disease as determined by improvements in endothelial function, systemic inflammation and cardiac and cerebral vascular function.
Studietype
Intervensjonell
Registrering (Faktiske)
58
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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British Columbia
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Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Non-smokers (>6 months);
- Forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) < 0.7 and FEV1/FVC <lower limit of normal
- Stable (>3 months exacerbation free)
Exclusion Criteria:
- On supplemental oxygen;
- Known cardiac or cerebral vascular disease, diabetes, obstructive sleep apnea;
- Uncontrolled hypertension;
- BMI >30kg/m2
- Currently performing pulmonary rehabilitation or structured exercise training;
- Desaturate during exercise (SpO2<85%)
- Cardiovascular contraindications to exercise in the incremental test used for screening
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Patients with COPD
Stable patients with COPD participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
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Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
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Aktiv komparator: Healthy Controls
Age, sex, BMI and activity matched controls participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
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Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Endothelial Function
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in brachial artery flow mediated dilation measured using reactive hyperaemia
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8-weeks (following 24 sessions of exercise training)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Arterial Stiffness
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in pulse wave velocity measured using tonometry
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8-weeks (following 24 sessions of exercise training)
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Carotid intima-medial thickness
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in carotid intima-medial thickness measured by ultrasound
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8-weeks (following 24 sessions of exercise training)
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Carotid Compliance
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
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8-weeks (following 24 sessions of exercise training)
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Inflammatory Biomarkers
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
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8-weeks (following 24 sessions of exercise training)
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Systolic function
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in stroke volume using echocardiography
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8-weeks (following 24 sessions of exercise training)
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Diastolic function
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in left ventricular end-diastolic volume using echocardiography
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8-weeks (following 24 sessions of exercise training)
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Cerebral Blood Flow
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in cerebral and neck blood flow using ultrasound
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8-weeks (following 24 sessions of exercise training)
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Cerebrovascular Reactivity
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in middle cerebral artery velocity in response to carbon dioxide
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8-weeks (following 24 sessions of exercise training)
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Cerebrovascular Autoregulation
Tidsramme: 8-weeks (following 24 sessions of exercise training)
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The change in phase delay measured by transfer function analysis
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8-weeks (following 24 sessions of exercise training)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Neil Eves, PhD, University of British Columbia
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Gelinas JC, Lewis NC, Harper MI, Ainslie PN, Rolf JD, Eves ND. Aerobic Exercise Training on Peripheral Vascular Structure and Function in Patients with Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine, 191:A5305, 2015.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2012
Primær fullføring (Faktiske)
1. mai 2015
Studiet fullført (Faktiske)
1. mai 2015
Datoer for studieregistrering
Først innsendt
4. august 2016
Først innsendt som oppfylte QC-kriteriene
17. august 2016
Først lagt ut (Anslag)
23. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H11-02770
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