High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study

University of Toronto

Status

Terminated

Conditions

Prostate Cancer

Treatments

Behavioral: High-intensity interval training (HIIT)

Behavioral: High-Intensity resistance training (HIRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04266262

16-6340

Details and patient eligibility

About

This is a randomized study aiming to assess the feasibility of a phase II randomized controlled trial of different high-intensity training interventions and usual care (UC) in men with prostate cancer (PCa) undergoing active surveillance (AS).

Full description

Primary objectives:

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.

Enrollment

25 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older;
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

uncontrolled hypertension (≥2/3 of readings of > 160/90), regardless of whether on a regimen of anti-hypertensive therapy or not;
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