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Clinical Trials/NCT02459132
NCT02459132CompletedNot Applicable

A Phase II Randomized Trial of High-Intensity Aerobic Interval Training and Surrogate Markers of Cardiovascular Disease in a Population-based Sample of Testicular Cancer Survivors

University of Alberta0 sites63 target enrollmentStarted: July 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
63
Primary Endpoint
Peak aerobic capacity (relative VO2peak)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study evaluates the impact of a supervised 12-week high-intensity aerobic interval exercise program (versus a self-directed exercise usual care group) on traditional and novel cardiovascular disease risk factors and surrogate markers of cardiovascular- and overall-mortality in a population-based sample of testicular cancer survivors.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •histologically confirmed history of testicular cancer

Exclusion Criteria

  • •Not sufficiently ambulatory to complete the first two stages of the aerobic exercise test.
  • •Have a psychiatric condition which impairs their ability to perform the required volume and intensity of exercise.
  • •Have any uncontrolled cardiovascular condition (i.e. heart disease, hypertension, diabetes, arrhythmia).
  • •Report performing any weekly vigorous intensity aerobic exercise in the past month.

Outcomes

Primary Outcomes

Peak aerobic capacity (relative VO2peak)

Time Frame: Baseline and within 7 days of completing the 12-week intervention

ml O2/kg/min

Secondary Outcomes

  • Peak aerobic capacity (absolute VO2peak)(Baseline and within 7 days of completing the 12-week intervention)
  • Postexercise 1-minute heart rate recovery(Baseline and within 7 days of completing the 12-week intervention)
  • Average carotid intima-media thickness(Baseline and within 7 days of completing the 12-week intervention)
  • Carotid distensibility(Baseline and within 7 days of completing the 12-week intervention)
  • Velocity time integral(Baseline and within 7 days of completing the 12-week intervention)
  • Respiratory sinus arrhythmia(Baseline and within 7 days of completing the 12-week intervention)
  • Diastolic blood pressure(Baseline and within 7 days of completing the 12-week intervention)
  • Brachial diameter(Baseline and within 7 days of completing the 12-week intervention)
  • Maximal carotid intima-media thickness(Baseline and within 7 days of completing the 12-week intervention)
  • Carotid diameter(Baseline and within 7 days of completing the 12-week intervention)
  • Brachial flow-mediated dilation(Baseline and within 7 days of completing the 12-week intervention)
  • Heart rate(Baseline and within 7 days of completing the 12-week intervention)
  • Systolic blood pressure(Baseline and within 7 days of completing the 12-week intervention)
  • Femoral-toe pulse wave velocity(Baseline and within 7 days of completing the 12-week intervention)
  • Low-density lipoprotein(Baseline and within 7 days of completing the 12-week intervention)
  • Total cholesterol : high-density lipoprotein ratio(Baseline and within 7 days of completing the 12-week intervention)
  • Vascular age(Baseline and within 7 days of completing the 12-week intervention)
  • Carotid-femoral pulse wave velocity(Baseline and within 7 days of completing the 12-week intervention)
  • Fibrinogen(Baseline and within 7 days of completing the 12-week intervention)
  • Total cholesterol(Baseline and within 7 days of completing the 12-week intervention)
  • Triglycerides(Baseline and within 7 days of completing the 12-week intervention)
  • Shear stress during reactive hyperemia(Baseline and within 7 days of completing the 12-week intervention)
  • High-density lipoprotein(Baseline and within 7 days of completing the 12-week intervention)
  • Testosterone(Baseline and within 7 days of completing the 12-week intervention)
  • Framingham Risk Score(Baseline and within 7 days of completing the 12-week intervention)
  • High-sensitivity C-reactive protein(Baseline and within 7 days of completing the 12-week intervention)
  • Fasting glucose(Baseline and within 7 days of completing the 12-week intervention)
  • Modifiable CVD Risk Factor Score(Baseline and within 7 days of completing the 12-week intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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High-Intensity Aerobic Interval Training... | Clinical Trial