Clinical trial · Interventional
High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
NCT04266262CI-TRIAL-00048110terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): All research activities were suspended as a result of COVID-19.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-intensity interval training (HIIT) | Behavioral | — | UNRESOLVED |
| High-Intensity resistance training (HIRT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High-Intensity interval training (HIIT)
- interventionNames
- Behavioral: High-intensity interval training (HIIT)
- type
- EXPERIMENTAL
- label
- High-intensity resistance training (HIRT)
- interventionNames
- Behavioral: High-Intensity resistance training (HIRT)
- type
- NO_INTERVENTION
- label
- Usual care (UC)
- description
- Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPapadopoulos 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. PMID 34380000