- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04266262
High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2W6
- University of Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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). |
Experimental: 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. |
No Intervention: Usual care (UC)
Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Initiation through end of study recruitment at 26 months
|
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
|
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)
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
|
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)
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
|
Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cardiorespiratory fitness
Time Frame: At baseline and 8 weeks (post-intervention)
|
Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)
|
At baseline and 8 weeks (post-intervention)
|
Changes in musculoskeletal strength
Time Frame: 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)
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At baseline and 8 weeks (post-intervention)
|
Changes in circulating cytokines
Time Frame: At baseline and 8 weeks (post-intervention)
|
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
Time Frame: 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
|
At baseline and 8 weeks (post-intervention)
|
Body composition
Time Frame: At baseline and 8 weeks (post-intervention)
|
Body mass will be measured using a weight scale (kg)
|
At baseline and 8 weeks (post-intervention)
|
Changes in waist circumference
Time Frame: At baseline and 8 weeks (post-intervention)
|
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
Time Frame: At baseline and 8 weeks (post-intervention)
|
% 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
Time Frame: At baseline and 8 weeks (post-intervention)
|
QoL will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
|
At baseline and 8 weeks (post-intervention)
|
Anxiety
Time Frame: 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)
|
At baseline and 8 weeks (post-intervention)
|
Fear of disease progression
Time Frame: 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)
|
At baseline and 8 weeks (post-intervention)
|
Physical activity status
Time Frame: At baseline and 8 weeks (post-intervention)
|
Changes in physical activity status will be measured using the Godin-Leisure Time Physical Activity Questionnaire (GLTEQ)
|
At baseline and 8 weeks (post-intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-6340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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