High-Intensity Aerobic Interval Training in Testicular Cancer Survivors

Cardiovascular Diseases Clinical Trial

— HIITTS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459132
• Other study ID #: HREBA.CC-14-0183
• Status: Completed
• Phase: N/A
• First received: May 21, 2015
• Last updated: April 20, 2017
• Start date: July 2015
• Est. completion date: April 2017

Study information

• Verified date: September 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Testicular Neoplasms

Intervention

Behavioral:
• High-intensity aerobic interval exercise
See arm/group description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Anxiety	Spielberger State Anxiety Scale	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Other	Stress	Perceived Stress Scale	Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Other	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
Primary	Peak aerobic capacity (relative VO2peak)	ml O2/kg/min	Baseline and within 7 days of completing the 12-week intervention
Secondary	Peak aerobic capacity (absolute VO2peak)	L/min	Baseline and within 7 days of completing the 12-week intervention
Secondary	Postexercise 1-minute heart rate recovery	change in beats/min	Baseline and within 7 days of completing the 12-week intervention
Secondary	Heart rate	beats/min	Baseline and within 7 days of completing the 12-week intervention
Secondary	Systolic blood pressure	mmHg	Baseline and within 7 days of completing the 12-week intervention
Secondary	Diastolic blood pressure	mmHg	Baseline and within 7 days of completing the 12-week intervention
Secondary	Respiratory sinus arrhythmia	beats/min	Baseline and within 7 days of completing the 12-week intervention
Secondary	Average carotid intima-media thickness	mm	Baseline and within 7 days of completing the 12-week intervention
Secondary	Maximal carotid intima-media thickness	mm	Baseline and within 7 days of completing the 12-week intervention
Secondary	Carotid distensibility	10-3/kPa	Baseline and within 7 days of completing the 12-week intervention
Secondary	Carotid diameter	mm	Baseline and within 7 days of completing the 12-week intervention
Secondary	Brachial flow-mediated dilation	percent dilation	Baseline and within 7 days of completing the 12-week intervention
Secondary	Brachial diameter	mm	Baseline and within 7 days of completing the 12-week intervention
Secondary	Velocity time integral	cm	Baseline and within 7 days of completing the 12-week intervention
Secondary	Shear stress during reactive hyperemia	dynes/cm2	Baseline and within 7 days of completing the 12-week intervention
Secondary	Carotid-femoral pulse wave velocity	m/s	Baseline and within 7 days of completing the 12-week intervention
Secondary	Femoral-toe pulse wave velocity	m/s	Baseline and within 7 days of completing the 12-week intervention
Secondary	Fibrinogen	g/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	High-sensitivity C-reactive protein	mg/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	Total cholesterol	mmol/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	High-density lipoprotein	mmol/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	Low-density lipoprotein	mmol/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	Total cholesterol : high-density lipoprotein ratio	ratio	Baseline and within 7 days of completing the 12-week intervention
Secondary	Triglycerides	mmol/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	Fasting glucose	mmol/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	Testosterone	nmol/L	Baseline and within 7 days of completing the 12-week intervention
Secondary	Framingham Risk Score	10 year CVD risk %	Baseline and within 7 days of completing the 12-week intervention
Secondary	Vascular age	years	Baseline and within 7 days of completing the 12-week intervention
Secondary	Modifiable CVD Risk Factor Score	Number (max 24)	Baseline and within 7 days of completing the 12-week intervention