Clinical trial NCT02459132: High-Intensity Aerobic Interval Training in Testicular Cancer Survivors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Testicular Neoplasms
Keywords: High-intensity interval training
VO2peak
Brachial flow-mediated dilation
Carotid-femoral pulse wave velocity
Carotid intima-media thickness
Carotid distensibility
Respiratory sinus arrhythmia
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Peak aerobic capacity (relative VO2peak)
timeFrame: Baseline and within 7 days of completing the 12-week intervention
Secondary outcomes:
measure: Peak aerobic capacity (absolute VO2peak)
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Postexercise 1-minute heart rate recovery
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Heart rate
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Systolic blood pressure
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Diastolic blood pressure
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Respiratory sinus arrhythmia
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Average carotid intima-media thickness
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Maximal carotid intima-media thickness
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Carotid distensibility
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Carotid diameter
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Brachial flow-mediated dilation
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Brachial diameter
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Velocity time integral
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Shear stress during reactive hyperemia
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Carotid-femoral pulse wave velocity
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Femoral-toe pulse wave velocity
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Fibrinogen
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: High-sensitivity C-reactive protein
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Total cholesterol
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: High-density lipoprotein
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Low-density lipoprotein
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Total cholesterol : high-density lipoprotein ratio
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Triglycerides
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Fasting glucose
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Testosterone
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Framingham Risk Score
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Vascular age
timeFrame: Baseline and within 7 days of completing the 12-week intervention
measure: Modifiable CVD Risk Factor Score
timeFrame: Baseline and within 7 days of completing the 12-week intervention
Other outcomes:
measure: Health-related quality of life
timeFrame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
measure: Depression
timeFrame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
measure: Fatigue
timeFrame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
measure: Sleep Quality
timeFrame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
measure: Anxiety
timeFrame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
measure: Stress
timeFrame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
measure: Self-Esteem
timeFrame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Locations:
Study officials:
affiliation: University of Alberta
name: Kerry S Courneya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams SC, DeLorey DS, Davenport MH, Stickland MK, Fairey AS, North S, Szczotka A, Courneya KS. Effects of high-intensity aerobic interval training on cardiovascular disease risk in testicular cancer survivors: A phase 2 randomized controlled trial. Cancer. 2017 Oct 15;123(20):4057-4065. doi: 10.1002/cncr.30859. Epub 2017 Jul 14.