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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: High-intensity interval training (HIIT)
* Behavioral: High-Intensity resistance training (HIRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Intensity interval training (HIIT)<br> | Behavioral: High-intensity interval training (HIIT)<br>* 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).<br>|
| Experimental: High-intensity resistance training (HIRT)<br> | Behavioral: High-Intensity resistance training (HIRT)<br>* 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.<br>|
| No Intervention: Usual care (UC)<br>Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate (feasibility target: ≥25% of eligible patients) | Percent of consenting participants relative to the total number of eligible participants approached | 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 | 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 | 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 | Initiation through end of study intervention period at a maximum of 8 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiorespiratory fitness | Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak) | 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) | At baseline and 8 weeks (post-intervention) | 
| Changes in circulating cytokines | TNFalpha, interleukin (IL)-6, and IL-10 will be assessed using blood samples | At baseline and 8 weeks (post-intervention) | 
| Changes in circulating growth factors | Insulin-like growth factor-1 (IGF-1) and insulin-like binding protein 3 (IGFBP-3) will be assessed using blood samples | At baseline and 8 weeks (post-intervention) | 
| Body composition | Body mass will be measured using a weight scale (kg) | At baseline and 8 weeks (post-intervention) | 
| Changes in waist circumference | Waist circumference will be measured using a measuring tape (cm) | At baseline and 8 weeks (post-intervention) | 
| Changes in body fat and lean body mass | % body fat and % lean body mass will be measured using a bioelectrical impedance analysis (BIA) scale | At baseline and 8 weeks (post-intervention) | 
| Changes in Quality of Life | QoL will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) | At baseline and 8 weeks (post-intervention) | 
| Anxiety | Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) and the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) | At baseline and 8 weeks (post-intervention) | 
| Fear of disease progression | Fear of disease progression will be measured using the Fear of Progression Questionnaire-Short Form (FOP-Q-SF) | At baseline and 8 weeks (post-intervention) | 
| Physical activity status | Changes in physical activity status will be measured using the Godin-Leisure Time Physical Activity Questionnaire (GLTEQ) | At baseline and 8 weeks (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active Surveillance, Prostate Cancer, High-intensity interval training, Resistance training