Prostate CancerNCT04266262
High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
A study testing High-intensity interval training (HIIT) and High-Intensity resistance training (HIRT) in people with Prostate Cancer, run by University of Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High-intensity interval training (HIIT) and High-Intensity resistance training (HIRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2018to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- High-intensity interval training (HIIT), High-Intensity resistance training (HIRT)
- Keywords
- Active Surveillance, Prostate Cancer, High-intensity interval training, Resistance training
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training (HIIT)Behavioural
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).
High-Intensity resistance training (HIRT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity interval training (HIIT) | Experimental | Not described Receives: Behavioral: High-intensity interval training (HIIT) |
| High-intensity resistance training (HIRT) | Experimental | Not described Receives: Behavioral: High-Intensity resistance training (HIRT) |
| Usual care (UC) | No intervention | Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate (feasibility target: ≥25% of eligible patients)
Percent of consenting participants relative to the total number of eligible participants approached
Measured: 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
Measured: 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
Measured: 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
Measured: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Secondary outcomes (11)
Changes in cardiorespiratory fitness
Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)
Measured: 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)
Measured: At baseline and 8 weeks (post-intervention)
Changes in circulating cytokines
TNFalpha, interleukin (IL)-6, and IL-10 will be assessed using blood samples
Measured: 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
Measured: At baseline and 8 weeks (post-intervention)
Body composition
Body mass will be measured using a weight scale (kg)
Measured: At baseline and 8 weeks (post-intervention)
Changes in waist circumference
Waist circumference will be measured using a measuring tape (cm)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At baseline and 8 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start9 Jul 2018
- Primary completion18 Mar 2020
- Study completion20 Mar 2020
Why it stopped: All research activities were suspended as a result of COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Daniel Santa Mina, PhD, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266262
- Sponsor's protocol ID
- 16-6340
- Status last verified
- Nov 2020
- First submitted
- 6 Feb 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of this study will be available from the corresponding author upon reasonable request
Publications
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.
PubMed 34380000
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04266262
- Acronym / sponsor ID
- 16-6340
- Conditions
- Prostate Cancer
- Keywords
- Active Surveillance, Prostate Cancer, High-intensity interval training, Resistance training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All research activities were suspended as a result of COVID-19.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity interval training (HIIT) | Experimental | Behavioral: High-intensity interval training (HIIT) |
| High-intensity resistance training (HIRT) | Experimental | Behavioral: High-Intensity resistance training (HIRT) |
| Usual care (UC) | No intervention | –Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-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). | Behavioural | High-Intensity interval training (HIIT) |
| High-Intensity resistance training (HIRT)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. | Behavioural | High-intensity resistance training (HIRT) |
Primary outcome
Recruitment rate (feasibility target: ≥25% of eligible patients)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
11 secondary outcomes
Changes in cardiorespiratory fitness
Time frame: At baseline and 8 weeks (post-intervention)
Changes in musculoskeletal strength
Time frame: At baseline and 8 weeks (post-intervention)
Changes in circulating cytokines
Time frame: At baseline and 8 weeks (post-intervention)
Changes in circulating growth factors
Time frame: At baseline and 8 weeks (post-intervention)
Body composition
Time frame: At baseline and 8 weeks (post-intervention)
Changes in waist circumference
Time frame: At baseline and 8 weeks (post-intervention)
Changes in body fat and lean body mass
Time frame: At baseline and 8 weeks (post-intervention)
Changes in Quality of Life
Time frame: At baseline and 8 weeks (post-intervention)
Anxiety
Time frame: At baseline and 8 weeks (post-intervention)
Fear of disease progression
Time frame: At baseline and 8 weeks (post-intervention)
Physical activity status
Time frame: At baseline and 8 weeks (post-intervention)
Results and safety
The study was stopped early (reason given: All research activities were suspended as a result of COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 34380000Papadopoulos 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.
- Individual participant dataSharing planned: Yes. The data of this study will be available from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training (HIIT) and High-Intensity resistance training (HIRT) in people with Prostate Cancer, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: All research activities were suspended as a result of COVID-19.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (feasibility target: ≥25% of eligible patients) (time frame: Initiation through end of study recruitment at 26 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.