High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
NCT ID: NCT04266262
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
25 participants
INTERVENTIONAL
2018-07-09
2020-03-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary objective of this study is to assess the feasibility of conducting a three-armed randomized controlled trial comparing high-intensity interval training (HIIT), high-intensity resistance training (HIRT), and usual care (UC) in men with PCa on AS.
The secondary exploratory objective of this study is to assess changes in cardiorespiratory fitness, musculoskeletal strength, body composition, circulating blood markers, and participant-self-reported outcomes (e.g., quality of life, anxiety, fear of disease progression) after 8 weeks of HIIT, HIRT, or UC.
Methods:
Participants will be randomized in a 1:1:1 ratio to HIIT, HIRT or UC group.
Participants in the HIIT and HIRT group will undergo training 3 times per week (two supervised and one home-based/unsupervised training session) for 8 weeks.
The UC group will be directed towards publicly available literature on physical activity (e.g., Cancer Care Ontario's physical activity guidelines for cancer survivors) and will receive an individualized exercise program upon completion of their final fitness assessment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High-Intensity interval training (HIIT)
High-intensity interval training (HIIT)
Supervised HIIT sessions (2x/week) will comprise cycling 10 x 60 secs at 85-95% maximum heart rate (HRmax) interspersed by 60 secs of low-intensity recovery.
Unsupervised HIIT sessions (1x/week) will involve 10 x 60 secs of walking or alternative (intensity of 7-9 on the 0-10 RPE) interspersed by 60 secs of walking or cycling at low intensity recovery (RPE 3-5).
High-intensity resistance training (HIRT)
High-Intensity resistance training (HIRT)
Supervised HIRT sessions (2x/week) will comprise 2-3 sets of 6-8 repetitions progressively achieving 85% of 1RM.
Unsupervised HIRT sessions (1x/week) will involve 2-3 sets of 15-20 repetitions using a resistance exercise band when necessary.
Usual care (UC)
Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High-intensity interval training (HIIT)
Supervised HIIT sessions (2x/week) will comprise cycling 10 x 60 secs at 85-95% maximum heart rate (HRmax) interspersed by 60 secs of low-intensity recovery.
Unsupervised HIIT sessions (1x/week) will involve 10 x 60 secs of walking or alternative (intensity of 7-9 on the 0-10 RPE) interspersed by 60 secs of walking or cycling at low intensity recovery (RPE 3-5).
High-Intensity resistance training (HIRT)
Supervised HIRT sessions (2x/week) will comprise 2-3 sets of 6-8 repetitions progressively achieving 85% of 1RM.
Unsupervised HIRT sessions (1x/week) will involve 2-3 sets of 15-20 repetitions using a resistance exercise band when necessary.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* initiating or currently on AS for PCa;
* not currently engaging in high-intensity aerobic and/or resistance training at 85%HRmax or ≥9 RPE in the Borg 0-10 RPE scale;
* willing and able to travel to the study-designated facilities;
* proficient in English;
* able to provide written informed consent;
* pass the screening CPET by achieving volitional exhaustion (rate of perceived exertion (RPE) ≥ 9 using the Borg 0-10 RPE scale) in the absence of any cardiorespiratory abnormalities.
Exclusion Criteria
* been diagnosed with congestive heart failure (New York Heart Association Class II, III or IV);
* a history of serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI);
* a medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the study physician, would make this protocol unreasonably hazardous for the patient;
* a history of a psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol;
* serious or non-healing wound, ulcer, or bone fracture;
* experience shortness of breath, chest discomfort, or palpitations when performing activities of daily living;
* ongoing restriction of physical activity;
* developed chest pain in the past month
18 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
University of Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Santa Mina, PhD
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Toronto
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Papadopoulos E, Gillen J, Moore D, Au D, Kurgan N, Klentrou P, Finelli A, Alibhai SMH, Santa Mina D. High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial. Appl Physiol Nutr Metab. 2021 Dec;46(12):1535-1544. doi: 10.1139/apnm-2021-0365. Epub 2021 Aug 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-6340
Identifier Type: -
Identifier Source: org_study_id