High-Intensity Aerobic Interval Training in Testicular Cancer Survivors (HIITTS)

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

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 Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Testicular Neoplasms
• Intervention / Treatment: Behavioral: High-intensity aerobic interval exercise

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; 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; See arm/group description
No Intervention: Usual Care; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	Short form 36	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Depression	Centre for epidemiologic studies depression scale	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Fatigue	Functional Assessment of Cancer Therapy - Fatigue	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Sleep Quality	Global Pittsburg Sleep Quality Index	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Anxiety	Spielberger State Anxiety Scale	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Stress	Perceived Stress Scale	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Self-Esteem	Rosenberg Self-Esteem Scale	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Kerry S Courneya, PhD, University of Alberta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: High-intensity interval training; VO2peak; Carotid intima-media thickness; Brachial flow-mediated dilation; Carotid-femoral pulse wave velocity; Carotid distensibility; Respiratory sinus arrhythmia
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Cardiovascular Diseases; Testicular Neoplasms
• Other Study ID Numbers: HREBA.CC-14-0183