Year-round Health Enhancing Exercise and Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT02855905|
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : November 1, 2017
A cold season involves higher cardiovascular morbidity and mortality. Several epidemiologic studies have implicated that persons with a cardiac disease, such as coronary artery disease (CAD) may be at higher risk for these adverse health events, but the mechanisms are not well established. Because both exercise and cold exposure stimulates cardiac and circulatory functions it is important to study their interaction especially among people with CAD and whose myocardial oxygen supply and function are weakened. The study examines how recommended health-enhancing upper and lower body exercise and warm-up in combination with cold exposure affects cardiovascular functions of people with CAD.
The research includes randomized controlled experiments where the participants are 35-75 year old men with CAD (CCS I-II) and recruited from the Oulu University Hospital. Each participant undergoes four different trials in random order where the temperature (+22°C or -15°C) and the form of exercise (brisk walking at 5.5 km/h or upper body exercise at 30 W), and warm-up regime is varied. The used exercise, clothing and exposure resemble an ordinary wintertime exercise event. Novel techniques are used to broadly assess cardiovascular function before, during and in the recovery phase.
The obtained information is synthesized and translated to tailored year-round exercise instructions for people with CAD by the research team including experts from sports sciences, physiology, public and occupational health, clinical sciences and with complementary knowledge in physical activity, effective interventions and cardiovascular function. The study has broad national and international impact on the relatively passive aging population having CAD and residing and working in a cold climate. The produced information enables finding means to activate persons with CAD and where appropriate and safe year-round exercise may reduce or prevent adverse health effects. Health care personnel will have an improved possibility to prescribe physical activity programs for their clients and enabling better instructions of healthy and safe exercise as a way to promote health.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Other: Exercise/Rest and cold/neutral temperature||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Year-round Health Enhancing Exercise and Coronary Artery Disease: Randomized Controlled Study|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Experimental: Coronary artery disease patients
Coronary artery disease patients are exposed to brief cold exposure (-15 C for 30 min) mainly subjected to facial region during which their cardiovascular responses are registered. Exposure was repeated 4 times: rest and exercise in 22 C and rest and exercise in -15 C.
Other: Exercise/Rest and cold/neutral temperature
Subjects were either exercising or resting in either cold or neutral environmental temperature
- Blood pressure [mmHg, millimeter of mercury] [ Time Frame: 3 hours ]Brachial blood pressure
- Electrocardiogram [mV, milliVolts] [ Time Frame: 3 hours ]online 12-lead monitoring and data collection of cardiac electric activity
- Flow-mediated dilation [arterial diameter mm, millimeter] [ Time Frame: 3 hours ]ultrasound measurement of brachial blood flow following occlusion
- Stress hormones (catecholamines) [nmol/l, nanomol / liter] [ Time Frame: 3 hours ]collection of blood samples from where the following parameters are analysed: noradrenaline and adrenaline.
- inflammatory markers [ng/l, nanogram / liter] [ Time Frame: 3 hours ]collection of blood samples from where the following parameters are analysed: interleukin-6, c-reactive protein and (tumor necrosis factor) TNF-alpha
- blood coagulation factors [mg/l, milligram / liter] [ Time Frame: 3 hours ]collection of blood samples from where the following parameters are analysed: fibrinogen and protrombin
- Skin temperature [°C, celsius] [ Time Frame: 3 hours ]Skin temperature is measured by 8-channel temperature data loggers (SmartReaderPlus; Acr Systems, Surrey, BC, Canada). We have two data loggers and we use totally 10-channels. Thermistors are placed on the skin following places: right scapula, left side of the face, forehead, left calf, right anterior thigh, left index finger, left hand, left forearm, right shoulder, left upper chest.
- Central aortic blood pressure [mmHg, millimeter of mercury] [ Time Frame: 3 hours ]Central aortic BP is measured with the use of radial artery applanation tonometry. The measuring sensor is tonometric pressure sensor (SPC-301; Millar Instruments, Houston, Texas, USA). Tonometric pressure sensor is placed on the skin over the radial artery and the sensor transmits digitally the pulse of the artery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855905
|University of Oulu, Center for Environmental and Respiratory Health Research|
|Oulu, Finland, FI-90014|
|Principal Investigator:||Tiina M Ikäheimo, Ph.D.||University of Oulu, Center for Environmental and Respiratory Health Research|