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All research activities were suspended as a result of COVID-19.
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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity interval training (HIIT) | Experimental |
| |
| High-intensity resistance training (HIRT) | Experimental |
| |
| Usual care (UC) | No Intervention | Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toronto | Toronto | Ontario | M5S 2W6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34380000 | Derived | Papadopoulos E, Gillen J, Moore D, Au D, Kurgan N, Klentrou P, Finelli A, Alibhai SMH, Santa Mina D. High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial. Appl Physiol Nutr Metab. 2021 Dec;46(12):1535-1544. doi: 10.1139/apnm-2021-0365. Epub 2021 Aug 11. |
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The data of this study will be available from the corresponding author upon reasonable request
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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| 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. |
|
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) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |