High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
- Conditions
- Prostate Cancer
- Registration Number
- NCT04266262
- Lead Sponsor
- University of Toronto
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 25
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recruitment rate (feasibility target: ≥25% of eligible patients) Initiation through end of study recruitment at 26 months Percent of consenting participants relative to the total number of eligible participants approached
Compliance rate (feasibility target: ≥70% of the prescribed exercises within supervised sessions) Initiation through end of study intervention period at a maximum of 8 weeks post-randomization Percent of completed repetitions relative to the total number of prescribed repetitions
Attendance rate (feasibility target: ≥70% to facility-based sessions) Initiation through end of study intervention period at a maximum of 8 weeks post-randomization Percent of completed facility-based sessions relative to the total number of prescribed facility-based sessions
Retention rate (feasibility target: 70% of participants consented to study) Initiation through end of study intervention period at a maximum of 8 weeks post-randomization Percent of participants that completed the study relative to the total number of participants consented to the study
- Secondary Outcome Measures
Name Time Method Changes in circulating cytokines At baseline and 8 weeks (post-intervention) TNFalpha, interleukin (IL)-6, and IL-10 will be assessed using blood samples
Changes in cardiorespiratory fitness At baseline and 8 weeks (post-intervention) Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)
Body composition At baseline and 8 weeks (post-intervention) Body mass will be measured using a weight scale (kg)
Changes in body fat and lean body mass At baseline and 8 weeks (post-intervention) % body fat and % lean body mass will be measured using a bioelectrical impedance analysis (BIA) scale
Changes in Quality of Life At baseline and 8 weeks (post-intervention) QoL will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Physical activity status At baseline and 8 weeks (post-intervention) Changes in physical activity status will be measured using the Godin-Leisure Time Physical Activity Questionnaire (GLTEQ)
Changes in musculoskeletal strength At baseline and 8 weeks (post-intervention) 1 repetition maximum (1RM) will be assessed for upper (e.g., seated row and chest press) and lower body (e.g., leg press)
Changes in circulating growth factors At baseline and 8 weeks (post-intervention) Insulin-like growth factor-1 (IGF-1) and insulin-like binding protein 3 (IGFBP-3) will be assessed using blood samples
Changes in waist circumference At baseline and 8 weeks (post-intervention) Waist circumference will be measured using a measuring tape (cm)
Anxiety At baseline and 8 weeks (post-intervention) Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) and the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Fear of disease progression At baseline and 8 weeks (post-intervention) Fear of disease progression will be measured using the Fear of Progression Questionnaire-Short Form (FOP-Q-SF)
Trial Locations
- Locations (1)
University of Toronto
🇨🇦Toronto, Ontario, Canada
University of Toronto🇨🇦Toronto, Ontario, Canada