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Trial record 1 of 1 for:    NCT02855905
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Year-round Health Enhancing Exercise and Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855905
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : November 1, 2017
Sponsor:
Collaborators:
Finnish Institute of Occupational Health
University of Texas Southwestern Medical Center
Maastricht University
Finnish Defense Forces
Information provided by (Responsible Party):
University of Oulu

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Blood pressure [mmHg, millimeter of mercury] [ Time Frame: 3 hours ]
    Brachial blood pressure


Secondary Outcome Measures :
  1. Electrocardiogram [mV, milliVolts] [ Time Frame: 3 hours ]
    online 12-lead monitoring and data collection of cardiac electric activity

  2. Flow-mediated dilation [arterial diameter mm, millimeter] [ Time Frame: 3 hours ]
    ultrasound measurement of brachial blood flow following occlusion

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CCS class I-II
  • Non-smokers
  • Hypertension
  • Myocardial infarction over 3 months ago

Exclusion Criteria:

  • smoking
  • Asthma
  • NYHA CCS class III-IV
  • Diabetes
  • Myocardial infarction less than 3 months ago
  • Chronic atrial fibrillation
  • Claudication
  • Unstable angina pectoris
  • Serious complex arrhythmias or ECG anomalies during rest.
  • Bypass surgery
  • Angioplasty

Information from the National Library of Medicine

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


Locations
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Finland
University of Oulu, Center for Environmental and Respiratory Health Research
Oulu, Finland, FI-90014
Sponsors and Collaborators
University of Oulu
Finnish Institute of Occupational Health
University of Texas Southwestern Medical Center
Maastricht University
Finnish Defense Forces
Investigators
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Principal Investigator: Tiina M Ikäheimo, Ph.D. University of Oulu, Center for Environmental and Respiratory Health Research
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT02855905    
Other Study ID Numbers: University of oulu/CadColdEx
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Oulu:
Exercise
Cold Temperature
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases