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

University of Toronto25 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

High-intensity interval training (HIIT)BEHAVIORAL

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)BEHAVIORAL

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

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Toronto

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Recruitment rate (feasibility target: ≥25% of eligible patients)

Percent of consenting participants relative to the total number of eligible participants approached

Time frame: Initiation through end of study recruitment at 26 months

Attendance rate (feasibility target: ≥70% to facility-based sessions)

Percent of completed facility-based sessions relative to the total number of prescribed facility-based sessions

Time frame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization

Compliance rate (feasibility target: ≥70% of the prescribed exercises within supervised sessions)

Percent of completed repetitions relative to the total number of prescribed repetitions

Time frame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization

Retention rate (feasibility target: 70% of participants consented to study)

Percent of participants that completed the study relative to the total number of participants consented to the study

Time frame: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization

Secondary Outcomes

Changes in cardiorespiratory fitness

Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)

Time frame: At baseline and 8 weeks (post-intervention)

Changes in musculoskeletal strength

1 repetition maximum (1RM) will be assessed for upper (e.g., seated row and chest press) and lower body (e.g., leg press)

Time frame: At baseline and 8 weeks (post-intervention)

Data from ClinicalTrials.gov

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