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

Primary Purpose

Cardiovascular Diseases, Testicular Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-intensity aerobic interval exercise
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring High-intensity interval training, VO2peak, Brachial flow-mediated dilation, Carotid-femoral pulse wave velocity, Carotid intima-media thickness, Carotid distensibility, Respiratory sinus arrhythmia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise Group

    Usual Care

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Peak aerobic capacity (relative VO2peak)
    ml O2/kg/min

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 21, 2015
    Last Updated
    April 20, 2017
    Sponsor
    University of Alberta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02459132
    Brief Title
    High-Intensity Aerobic Interval Training in Testicular Cancer Survivors
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alberta

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Testicular Neoplasms
    Keywords
    High-intensity interval training, VO2peak, Brachial flow-mediated dilation, Carotid-femoral pulse wave velocity, Carotid intima-media thickness, Carotid distensibility, Respiratory sinus arrhythmia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    The usual care group will not receive an intervention, and they will be asked to maintain baseline physical activity levels throughout the observation period.
    Intervention Type
    Behavioral
    Intervention Name(s)
    High-intensity aerobic interval exercise
    Intervention Description
    See arm/group description
    Primary Outcome Measure Information:
    Title
    Peak aerobic capacity (relative VO2peak)
    Description
    ml O2/kg/min
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Secondary Outcome Measure Information:
    Title
    Peak aerobic capacity (absolute VO2peak)
    Description
    L/min
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Postexercise 1-minute heart rate recovery
    Description
    change in beats/min
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Heart rate
    Description
    beats/min
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Systolic blood pressure
    Description
    mmHg
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Diastolic blood pressure
    Description
    mmHg
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Respiratory sinus arrhythmia
    Description
    beats/min
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Average carotid intima-media thickness
    Description
    mm
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Maximal carotid intima-media thickness
    Description
    mm
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Carotid distensibility
    Description
    10-3/kPa
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Carotid diameter
    Description
    mm
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Brachial flow-mediated dilation
    Description
    percent dilation
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Brachial diameter
    Description
    mm
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Velocity time integral
    Description
    cm
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Shear stress during reactive hyperemia
    Description
    dynes/cm2
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Carotid-femoral pulse wave velocity
    Description
    m/s
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Femoral-toe pulse wave velocity
    Description
    m/s
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Fibrinogen
    Description
    g/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    High-sensitivity C-reactive protein
    Description
    mg/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Total cholesterol
    Description
    mmol/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    High-density lipoprotein
    Description
    mmol/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Low-density lipoprotein
    Description
    mmol/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Total cholesterol : high-density lipoprotein ratio
    Description
    ratio
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Triglycerides
    Description
    mmol/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Fasting glucose
    Description
    mmol/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Testosterone
    Description
    nmol/L
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Framingham Risk Score
    Description
    10 year CVD risk %
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Vascular age
    Description
    years
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Title
    Modifiable CVD Risk Factor Score
    Description
    Number (max 24)
    Time Frame
    Baseline and within 7 days of completing the 12-week intervention
    Other Pre-specified Outcome Measures:
    Title
    Health-related quality of life
    Description
    Short form 36
    Time Frame
    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
    Title
    Depression
    Description
    Centre for epidemiologic studies depression scale
    Time Frame
    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
    Title
    Fatigue
    Description
    Functional Assessment of Cancer Therapy - Fatigue
    Time Frame
    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
    Title
    Sleep Quality
    Description
    Global Pittsburg Sleep Quality Index
    Time Frame
    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
    Title
    Anxiety
    Description
    Spielberger State Anxiety Scale
    Time Frame
    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
    Title
    Stress
    Description
    Perceived Stress Scale
    Time Frame
    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing
    Title
    Self-Esteem
    Description
    Rosenberg Self-Esteem Scale
    Time Frame
    Baseline, within 7 days of completing the 12-week intervention, and approximately 3 months after the post-intervention testing

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kerry S Courneya, PhD
    Organizational Affiliation
    University of Alberta
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28708930
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    High-Intensity Aerobic Interval Training in Testicular Cancer Survivors

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