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

April 20, 2017 updated by: University of Alberta

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak aerobic capacity (relative VO2peak)
Time Frame: Baseline and within 7 days of completing the 12-week intervention
ml O2/kg/min
Baseline and within 7 days of completing the 12-week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak aerobic capacity (absolute VO2peak)
Time Frame: Baseline and within 7 days of completing the 12-week intervention
L/min
Baseline and within 7 days of completing the 12-week intervention
Postexercise 1-minute heart rate recovery
Time Frame: Baseline and within 7 days of completing the 12-week intervention
change in beats/min
Baseline and within 7 days of completing the 12-week intervention
Heart rate
Time Frame: Baseline and within 7 days of completing the 12-week intervention
beats/min
Baseline and within 7 days of completing the 12-week intervention
Systolic blood pressure
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mmHg
Baseline and within 7 days of completing the 12-week intervention
Diastolic blood pressure
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mmHg
Baseline and within 7 days of completing the 12-week intervention
Respiratory sinus arrhythmia
Time Frame: Baseline and within 7 days of completing the 12-week intervention
beats/min
Baseline and within 7 days of completing the 12-week intervention
Average carotid intima-media thickness
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mm
Baseline and within 7 days of completing the 12-week intervention
Maximal carotid intima-media thickness
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mm
Baseline and within 7 days of completing the 12-week intervention
Carotid distensibility
Time Frame: Baseline and within 7 days of completing the 12-week intervention
10-3/kPa
Baseline and within 7 days of completing the 12-week intervention
Carotid diameter
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mm
Baseline and within 7 days of completing the 12-week intervention
Brachial flow-mediated dilation
Time Frame: Baseline and within 7 days of completing the 12-week intervention
percent dilation
Baseline and within 7 days of completing the 12-week intervention
Brachial diameter
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mm
Baseline and within 7 days of completing the 12-week intervention
Velocity time integral
Time Frame: Baseline and within 7 days of completing the 12-week intervention
cm
Baseline and within 7 days of completing the 12-week intervention
Shear stress during reactive hyperemia
Time Frame: Baseline and within 7 days of completing the 12-week intervention
dynes/cm2
Baseline and within 7 days of completing the 12-week intervention
Carotid-femoral pulse wave velocity
Time Frame: Baseline and within 7 days of completing the 12-week intervention
m/s
Baseline and within 7 days of completing the 12-week intervention
Femoral-toe pulse wave velocity
Time Frame: Baseline and within 7 days of completing the 12-week intervention
m/s
Baseline and within 7 days of completing the 12-week intervention
Fibrinogen
Time Frame: Baseline and within 7 days of completing the 12-week intervention
g/L
Baseline and within 7 days of completing the 12-week intervention
High-sensitivity C-reactive protein
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mg/L
Baseline and within 7 days of completing the 12-week intervention
Total cholesterol
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mmol/L
Baseline and within 7 days of completing the 12-week intervention
High-density lipoprotein
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mmol/L
Baseline and within 7 days of completing the 12-week intervention
Low-density lipoprotein
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mmol/L
Baseline and within 7 days of completing the 12-week intervention
Total cholesterol : high-density lipoprotein ratio
Time Frame: Baseline and within 7 days of completing the 12-week intervention
ratio
Baseline and within 7 days of completing the 12-week intervention
Triglycerides
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mmol/L
Baseline and within 7 days of completing the 12-week intervention
Fasting glucose
Time Frame: Baseline and within 7 days of completing the 12-week intervention
mmol/L
Baseline and within 7 days of completing the 12-week intervention
Testosterone
Time Frame: Baseline and within 7 days of completing the 12-week intervention
nmol/L
Baseline and within 7 days of completing the 12-week intervention
Framingham Risk Score
Time Frame: Baseline and within 7 days of completing the 12-week intervention
10 year CVD risk %
Baseline and within 7 days of completing the 12-week intervention
Vascular age
Time Frame: Baseline and within 7 days of completing the 12-week intervention
years
Baseline and within 7 days of completing the 12-week intervention
Modifiable CVD Risk Factor Score
Time Frame: Baseline and within 7 days of completing the 12-week intervention
Number (max 24)
Baseline and within 7 days of completing the 12-week intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Short form 36
Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Depression
Time Frame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
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
Time Frame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
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
Time Frame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
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
Time Frame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Spielberger State Anxiety Scale
Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Stress
Time Frame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Perceived Stress Scale
Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
Self-Esteem
Time Frame: Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kerry S Courneya, PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREBA.CC-14-0183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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