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Cardiovascular DiseasesHIITTSNCT02459132

High-Intensity Aerobic Interval Training in Testicular Cancer Survivors

A study testing High-intensity aerobic interval exercise in people with Cardiovascular Diseases and Testicular Neoplasms, run by University of Alberta.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Cardiovascular Diseases, Testicular Neoplasms
What is being tested?
High-intensity aerobic interval exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
No sites listed yet
Study dates
Jul 2015to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically confirmed history of testicular cancer

Who cannot join

  • 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.

About this study

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

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.

Being tested
High-intensity aerobic interval exercise
Keywords
High-intensity interval training, VO2peak, Brachial flow-mediated dilation, Carotid-femoral pulse wave velocity, Carotid intima-media thickness, Carotid distensibility, Respiratory sinus arrhythmia
Medical subject headings
Cardiovascular Diseases, Testicular Neoplasms, Arrhythmia, Sinus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity aerobic interval exerciseBehavioural

    See arm/group description

Study groups in NCT02459132
Study groupRoleWhat they receive
Exercise GroupExperimentalSubjects 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.
Receives: Behavioral: High-intensity aerobic interval exercise
Usual CareNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak aerobic capacity (relative VO2peak)

    ml O2/kg/min

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

Secondary outcomes (28)

  1. Peak aerobic capacity (absolute VO2peak)

    L/min

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

  2. Postexercise 1-minute heart rate recovery

    change in beats/min

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

  3. Heart rate

    beats/min

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

  4. Systolic blood pressure

    mmHg

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

  5. Diastolic blood pressure

    mmHg

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

  6. Respiratory sinus arrhythmia

    beats/min

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

  7. Average carotid intima-media thickness

    mm

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

  8. Maximal carotid intima-media thickness

    mm

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

  9. Carotid distensibility

    10-3/kPa

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

  10. Carotid diameter

    mm

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

  11. Brachial flow-mediated dilation

    percent dilation

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

  12. Brachial diameter

    mm

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

  13. Velocity time integral

    cm

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

  14. Shear stress during reactive hyperemia

    dynes/cm2

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

  15. Carotid-femoral pulse wave velocity

    m/s

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

  16. Femoral-toe pulse wave velocity

    m/s

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

  17. Fibrinogen

    g/L

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

  18. High-sensitivity C-reactive protein

    mg/L

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

  19. Total cholesterol

    mmol/L

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

  20. High-density lipoprotein

    mmol/L

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

  21. Low-density lipoprotein

    mmol/L

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

  22. Total cholesterol : high-density lipoprotein ratio

    ratio

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

  23. Triglycerides

    mmol/L

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

  24. Fasting glucose

    mmol/L

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

  25. Testosterone

    nmol/L

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

  26. Framingham Risk Score

    10 year CVD risk %

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

  27. Vascular age

    years

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

  28. Modifiable CVD Risk Factor Score

    Number (max 24)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionSep 2016
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459132
Sponsor's protocol ID
HREBA.CC-14-0183
Acronym
HIITTS
Status last verified
Sep 2016
First submitted
21 May 2015
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28708930

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity aerobic interval exercise in people with Cardiovascular Diseases and Testicular Neoplasms, run by University of Alberta.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak aerobic capacity (relative VO2peak) (time frame: Baseline and within 7 days of completing the 12-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459132, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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