High-Intensity Aerobic Interval Training in Testicular Cancer Survivors

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.

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

Conditions
-----------------
Cardiovascular Diseases, Testicular Neoplasms

Intervention / Treatment
-----------------
* Behavioral: High-intensity aerobic interval exercise


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>Subjects in the exercise group will attend supervised exercise sessions three times a week, for 12 weeks. The exercise intervention will consist of uphill walking or jogging on a treadmill between 50% and 95% of VO2peak for 35 minutes (including a 5-minute warm up and cool down). The participants will complete four, 4-minute, high-intensity intervals at 85-95% of VO2peak. The work period intervals will be interspersed with three, 3-minute periods of active recovery at an intensity below that of their ventilatory threshold. | Behavioral: High-intensity aerobic interval exercise<br>* See arm/group description<br>|
| No Intervention: Usual Care<br>The usual care group will not receive an intervention, and they will be asked to maintain baseline physical activity levels throughout the observation period. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak aerobic capacity (relative VO2peak) | ml O2/kg/min | Baseline and within 7 days of completing the 12-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak aerobic capacity (absolute VO2peak) | L/min | Baseline and within 7 days of completing the 12-week intervention | 
| Postexercise 1-minute heart rate recovery | change in beats/min | Baseline and within 7 days of completing the 12-week intervention | 
| Heart rate | beats/min | Baseline and within 7 days of completing the 12-week intervention | 
| Systolic blood pressure | mmHg | Baseline and within 7 days of completing the 12-week intervention | 
| Diastolic blood pressure | mmHg | Baseline and within 7 days of completing the 12-week intervention | 
| Respiratory sinus arrhythmia | beats/min | Baseline and within 7 days of completing the 12-week intervention | 
| Average carotid intima-media thickness | mm | Baseline and within 7 days of completing the 12-week intervention | 
| Maximal carotid intima-media thickness | mm | Baseline and within 7 days of completing the 12-week intervention | 
| Carotid distensibility | 10-3/kPa | Baseline and within 7 days of completing the 12-week intervention | 
| Carotid diameter | mm | Baseline and within 7 days of completing the 12-week intervention | 
| Brachial flow-mediated dilation | percent dilation | Baseline and within 7 days of completing the 12-week intervention | 
| Brachial diameter | mm | Baseline and within 7 days of completing the 12-week intervention | 
| Velocity time integral | cm | Baseline and within 7 days of completing the 12-week intervention | 
| Shear stress during reactive hyperemia | dynes/cm2 | Baseline and within 7 days of completing the 12-week intervention | 
| Carotid-femoral pulse wave velocity | m/s | Baseline and within 7 days of completing the 12-week intervention | 
| Femoral-toe pulse wave velocity | m/s | Baseline and within 7 days of completing the 12-week intervention | 
| Fibrinogen | g/L | Baseline and within 7 days of completing the 12-week intervention | 
| High-sensitivity C-reactive protein | mg/L | Baseline and within 7 days of completing the 12-week intervention | 
| Total cholesterol | mmol/L | Baseline and within 7 days of completing the 12-week intervention | 
| High-density lipoprotein | mmol/L | Baseline and within 7 days of completing the 12-week intervention | 
| Low-density lipoprotein | mmol/L | Baseline and within 7 days of completing the 12-week intervention | 
| Total cholesterol : high-density lipoprotein ratio | ratio | Baseline and within 7 days of completing the 12-week intervention | 
| Triglycerides | mmol/L | Baseline and within 7 days of completing the 12-week intervention | 
| Fasting glucose | mmol/L | Baseline and within 7 days of completing the 12-week intervention | 
| Testosterone | nmol/L | Baseline and within 7 days of completing the 12-week intervention | 
| Framingham Risk Score | 10 year CVD risk % | Baseline and within 7 days of completing the 12-week intervention | 
| Vascular age | years | Baseline and within 7 days of completing the 12-week intervention | 
| Modifiable CVD Risk Factor Score | Number (max 24) | Baseline and within 7 days of completing the 12-week intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-intensity interval training, VO2peak, Brachial flow-mediated dilation, Carotid-femoral pulse wave velocity, Carotid intima-media thickness, Carotid distensibility, Respiratory sinus arrhythmia