NCT02459132

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 21, 2017

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

May 21, 2015

Last Update Submit

April 20, 2017

Conditions

Cardiovascular DiseasesTesticular Neoplasms

Keywords

High-intensity interval trainingVO2peakBrachial flow-mediated dilationCarotid-femoral pulse wave velocityCarotid intima-media thicknessCarotid distensibilityRespiratory sinus arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Peak aerobic capacity (relative VO2peak)

    ml O2/kg/min

    Baseline and within 7 days of completing the 12-week intervention

Secondary Outcomes (28)

  • Peak aerobic capacity (absolute VO2peak)

    Baseline and within 7 days of completing the 12-week intervention

  • Postexercise 1-minute heart rate recovery

    Baseline and within 7 days of completing the 12-week intervention

  • Heart rate

    Baseline and within 7 days of completing the 12-week intervention

  • Systolic blood pressure

    Baseline and within 7 days of completing the 12-week intervention

  • Diastolic blood pressure

    Baseline and within 7 days of completing the 12-week intervention

  • +23 more secondary outcomes

Other Outcomes (7)

  • Health-related quality of life

    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing

  • Depression

    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing

  • Fatigue

    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing

  • +4 more other outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

The usual care group will not receive an intervention, and they will be asked to maintain baseline physical activity levels throughout the observation period.

Interventions

High-intensity aerobic interval exerciseBEHAVIORAL

See arm/group description

Exercise Group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed history of testicular cancer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28708930DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesTesticular NeoplasmsArrhythmia, Sinus

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kerry S Courneya, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

June 1, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2016

Study Completion

April 1, 2017

Last Updated

April 21, 2017

Record last verified: 2016-09