NCT02855905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

June 23, 2016

Last Update Submit

October 31, 2017

Conditions

Coronary Artery Disease

Keywords

ExerciseCold Temperature

Outcome Measures

Primary Outcomes (1)

  • Blood pressure [mmHg, millimeter of mercury]

    Brachial blood pressure

    3 hours

Secondary Outcomes (7)

  • Electrocardiogram [mV, milliVolts]

    3 hours

  • Flow-mediated dilation [arterial diameter mm, millimeter]

    3 hours

  • Stress hormones (catecholamines) [nmol/l, nanomol / liter]

    3 hours

  • inflammatory markers [ng/l, nanogram / liter]

    3 hours

  • blood coagulation factors [mg/l, milligram / liter]

    3 hours

  • +2 more secondary outcomes

Study Arms (1)

Coronary artery disease patients

EXPERIMENTAL

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

Interventions

Exercise/Rest and cold/neutral temperatureOTHER

Subjects were either exercising or resting in either cold or neutral environmental temperature

Coronary artery disease patients

Eligibility Criteria

Age35 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu, Center for Environmental and Respiratory Health Research

Oulu, FI-90014, Finland

Location

Related Publications (9)

  • Ikaheimo TM, Lehtinen T, Antikainen R, Jokelainen J, Nayha S, Hassi J, Keinanen-Kiukaanniemi S, Laatikainen T, Jousilahti P, Jaakkola JJ. Cold-related cardiorespiratory symptoms among subjects with and without hypertension: the National FINRISK Study 2002. Eur J Public Health. 2014 Apr;24(2):237-43. doi: 10.1093/eurpub/ckt078. Epub 2013 Jun 22.

    PMID: 23794677RESULT

  • Sun Z. Cardiovascular responses to cold exposure. Front Biosci (Elite Ed). 2010 Jan 1;2(2):495-503. doi: 10.2741/e108.

    PMID: 20036896RESULT

  • Hintsala H, Kandelberg A, Herzig KH, Rintamaki H, Mantysaari M, Rantala A, Antikainen R, Keinanen-Kiukaanniemi S, Jaakkola JJ, Ikaheimo TM. Central aortic blood pressure of hypertensive men during short-term cold exposure. Am J Hypertens. 2014 May;27(5):656-64. doi: 10.1093/ajh/hpt136. Epub 2013 Aug 20.

    PMID: 23964061RESULT

  • Hintsala H, Kentta TV, Tulppo M, Kiviniemi A, Huikuri HV, Mantysaari M, Keinanen-Kiukaannemi S, Bloigu R, Herzig KH, Antikainen R, Rintamaki H, Jaakkola JJ, Ikaheimo TM. Cardiac repolarization and autonomic regulation during short-term cold exposure in hypertensive men: an experimental study. PLoS One. 2014 Jul 1;9(7):e99973. doi: 10.1371/journal.pone.0099973. eCollection 2014.

    PMID: 24983379RESULT

  • Manou-Stathopoulou V, Goodwin CD, Patterson T, Redwood SR, Marber MS, Williams RP. The effects of cold and exercise on the cardiovascular system. Heart. 2015 May 15;101(10):808-20. doi: 10.1136/heartjnl-2014-306276. Epub 2015 Feb 11. No abstract available.

    PMID: 25673528RESULT

  • Pikkarainen K, Valtonen RIP, Hintsala HE, Kiviniemi A, Crandall CG, Perkiomaki J, Hautala AJ, Tulppo MP, Jaakkola JJK, Ikaheimo TM. Baroreflex sensitivity following acute upper-body exercise in the cold among stable coronary artery disease patients. Front Physiol. 2023 Oct 13;14:1184378. doi: 10.3389/fphys.2023.1184378. eCollection 2023.

    PMID: 37900953DERIVED

  • Valtonen RIP, Hintsala HHE, Kiviniemi A, Kentta T, Crandall C, van Marken Lichtenbelt W, Perkiomaki J, Hautala A, Jaakkola JJK, Ikaheimo TM. Cardiovascular responses to dynamic and static upper-body exercise in a cold environment in coronary artery disease patients. Eur J Appl Physiol. 2022 Jan;122(1):223-232. doi: 10.1007/s00421-021-04826-x. Epub 2021 Oct 16.

    PMID: 34655331DERIVED

  • Hintsala HE, Valtonen RIP, Kiviniemi A, Crandall C, Perkiomaki J, Hautala A, Mantysaari M, Alen M, Ryti N, Jaakkola JJK, Ikaheimo TM. Central aortic hemodynamics following acute lower and upper-body exercise in a cold environment among patients with coronary artery disease. Sci Rep. 2021 Jan 28;11(1):2550. doi: 10.1038/s41598-021-82155-x.

    PMID: 33510373DERIVED

  • Ikaheimo TM, Lansitie M, Valtonen R, Hintsala HE, Ryti N, Perkiomaki J, Mantysaari M, Hautala AJ, Jaakkola JJK. Good safety practice in a randomized controlled trial (CadColdEx) involving increased cardiac workload in patients with coronary artery disease. BMC Cardiovasc Disord. 2019 Mar 25;19(1):69. doi: 10.1186/s12872-019-1051-1.

    PMID: 30909877DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Study Officials

  • Tiina M Ikäheimo, Ph.D.

    University of Oulu, Center for Environmental and Respiratory Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

August 4, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

FI(1)