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Completed

NCT Number: NCT02459132

High-Intensity Aerobic Interval Training in 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.

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Key information

Conditions

Cardiovascular Diseases Arrhythmia, Sinus Arrhythmias, Cardiac Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Heart Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-intensity aerobic interval exercise

Behavioral

See arm/group description

Primary outcomes

  1. Peak aerobic capacity (relative VO2peak)

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

    ml O2/kg/min

Secondary outcomes

  1. Peak aerobic capacity (absolute VO2peak)

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

    L/min

  2. Postexercise 1-minute heart rate recovery

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

    change in beats/min

  3. Heart rate

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

    beats/min

  4. Systolic blood pressure

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

    mmHg

  5. Diastolic blood pressure

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

    mmHg

  6. Respiratory sinus arrhythmia

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

    beats/min

  7. Average carotid intima-media thickness

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

    mm

  8. Maximal carotid intima-media thickness

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

    mm

  9. Carotid distensibility

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

    10-3/kPa

  10. Carotid diameter

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

    mm

  11. Brachial flow-mediated dilation

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

    percent dilation

  12. Brachial diameter

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

    mm

  13. Velocity time integral

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

    cm

  14. Shear stress during reactive hyperemia

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

    dynes/cm2

  15. Carotid-femoral pulse wave velocity

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

    m/s

  16. Femoral-toe pulse wave velocity

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

    m/s

  17. Fibrinogen

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

    g/L

  18. High-sensitivity C-reactive protein

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

    mg/L

  19. Total cholesterol

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

    mmol/L

  20. High-density lipoprotein

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

    mmol/L

  21. Low-density lipoprotein

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

    mmol/L

  22. Total cholesterol : high-density lipoprotein ratio

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

    ratio

  23. Triglycerides

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

    mmol/L

  24. Fasting glucose

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

    mmol/L

  25. Testosterone

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

    nmol/L

  26. Framingham Risk Score

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

    10 year CVD risk %

  27. Vascular age

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

    years

  28. Modifiable CVD Risk Factor Score

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

    Number (max 24)

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study 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

Acronym: HIITTS

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 1, 2015
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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