- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02875522
The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
17 augusti 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
58
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
British Columbia
-
Kelowna, British Columbia, Kanada, V1V 1V7
- University of British Columbia
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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
|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Endothelial Function
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in brachial artery flow mediated dilation measured using reactive hyperaemia
|
8-weeks (following 24 sessions of exercise training)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Arterial Stiffness
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in pulse wave velocity measured using tonometry
|
8-weeks (following 24 sessions of exercise training)
|
|
Carotid intima-medial thickness
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in carotid intima-medial thickness measured by ultrasound
|
8-weeks (following 24 sessions of exercise training)
|
|
Carotid Compliance
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
|
8-weeks (following 24 sessions of exercise training)
|
|
Inflammatory Biomarkers
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
|
8-weeks (following 24 sessions of exercise training)
|
|
Systolic function
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in stroke volume using echocardiography
|
8-weeks (following 24 sessions of exercise training)
|
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Diastolic function
Tidsram: 8-weeks (following 24 sessions of exercise training)
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The change in left ventricular end-diastolic volume using echocardiography
|
8-weeks (following 24 sessions of exercise training)
|
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Cerebral Blood Flow
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in cerebral and neck blood flow using ultrasound
|
8-weeks (following 24 sessions of exercise training)
|
|
Cerebrovascular Reactivity
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in middle cerebral artery velocity in response to carbon dioxide
|
8-weeks (following 24 sessions of exercise training)
|
|
Cerebrovascular Autoregulation
Tidsram: 8-weeks (following 24 sessions of exercise training)
|
The change in phase delay measured by transfer function analysis
|
8-weeks (following 24 sessions of exercise training)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Neil Eves, PhD, University of British Columbia
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2012
Primärt slutförande (Faktisk)
1 maj 2015
Avslutad studie (Faktisk)
1 maj 2015
Studieregistreringsdatum
Först inskickad
4 augusti 2016
Först inskickad som uppfyllde QC-kriterierna
17 augusti 2016
Första postat (Uppskatta)
23 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H11-02770
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