Prostate Cancer
Conditions
Keywords
Active Surveillance, Prostate Cancer, High-intensity interval training, Resistance training
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.
Interventions
BEHAVIORALHigh-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).
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.
Sponsors
University Health Network, Toronto
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Body composition | At baseline and 8 weeks (post-intervention) | Body mass will be measured using a weight scale (kg) |
| Changes in waist circumference | At baseline and 8 weeks (post-intervention) | Waist circumference will be measured using a measuring tape (cm) |
| 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 cardiorespiratory fitness | At baseline and 8 weeks (post-intervention) | Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak) |
| 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) |
| 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 Quality of Life | At baseline and 8 weeks (post-intervention) | QoL will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) |
| 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 cytokines | At baseline and 8 weeks (post-intervention) | TNFalpha, interleukin (IL)-6, and IL-10 will be assessed using blood samples |
| 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 |
Countries
Canada
Outcome results
None listed