Prostate CancerNCT06828003
Feasibility of a Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer
A study testing Resistance Training in people with Prostate Cancer and Resistance Training, run by University of Toronto at 1 site in Canada.
Trial summary
Prostate cancer and its treatment are associated with many long-term adverse effects including cancer-related cognitive impairment. Specifically, androgen deprivation therapy has been shown to negatively impact cognitive function. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Resistance Training
- What is being tested?
- Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- localized or asymptomatic metastatic primary prostate cancer (i.e., androgen receptor axis agents [ARATs] including conventional ADT, abiraterone, enzalutamide)
- a history of ADT treatment
- not currently undergoing radiation
- no neurological or musculoskeletal co-morbidity inhibiting exercise
- mild cognitive impairment as determined by the TICS-M [scores between 21-24 to separate individuals with mild cognitive impairment and normal cognition (>24)]
Show all 10Show fewer
- not physically active (self-report <90 minutes of MVPA/week and <2 days of RT/week)
- physician clearance to participate
- access to a webcam and internet
- able to complete the study in English.
Who cannot join
- a medical condition that prevents unsupervised exercise
- presence of other primary or recurrent invasive cancer
- have experienced a fall in the last 12 months
- use a gait aid device
- current participation in other exercise programs/trials
- colour-blind since the objective cognitive tests require participants to distinguish between colours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Toronto
Toronto, Ontario, M5S2W6
Sarah O'Rourke, BA, 4169463624, s.orourke@mail.utoronto.ca
Linda Trinh, PhD, 4169463624, linda.trinh@utoronto.ca
About this study
Official title: A Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer: A Feasibility Study
Prostate cancer and its treatment are associated with many long-term adverse effects including cancer-related cognitive impairment. Specifically, androgen deprivation therapy has been shown to negatively impact cognitive function. Combined aerobic and resistance training has been shown to improve cognitive function in men treated with androgen deprivation therapy, but limited research has observed its impact into survivorship. Additionally, existing study designs are limited to supervised, combined aerobic and resistance training interventions. Remotely-delivered resistance training programs could enhance exercise participation by overcoming commonly reported barriers in men living with and beyond prostate cancer such as transportation, distance to facility, and timing of programs. Alongside the needs to address cancer-related cognitive impairments due to androgen deprivation therapy, resistance training may serve to manage functional deficits, losses in bone mineral density and muscle mass and increases in cardiometabolic risk factors. This study will assess the feasibility of an 8-week remotely-delivered resistance training program to improve cognitive function in men living with and beyond prostate cancer who have a history of androgen deprivation therapy treatment.
Read the detailed description
Prostate cancer and its treatment are associated with many long-term adverse effects including cognitive impairments which have been shown to improve with combined aerobic and resistance exercise. Existing exercise interventions have reported improved cognitive function for men treated with androgen deprivation therapy (ADT). Many of these studies, however, are limited by subjective measures of cognitive function and the use of a generalized quality of life questionnaire to capture cognitive function. Additionally, existing study designs are limited to supervised, combined aerobic and resistance training (RT) interventions. While combined aerobic and RT interventions elicit improvements in cognitive function following ADT, the independent effects of aerobic exercise and RT is less understood. Alongside the needs to address cancer-related cognitive impairments due to ADT, resistance training may serve to manage functional deficits, losses in bone mineral density and muscle mass and increases in cardiometabolic risk factors. There is indirect evidence to support a role for exercise training to attenuate the negative effects of ADT on cognitive function, however, a lack of research has been conducted with men living with and beyond prostate cancer (LWBPC). Given the unique treatment-related impacts on this patient group, there is a need for more adequately powered randomized controlled trials to investigate the direct effects of exercise, and independent effects of RT, on cognitive function in men LWBPC.
Remotely-delivered interventions may be an effective option to increase exercise among men LWBPC, while enhancing reach and accessibility by overcoming barriers to participation in traditional in-person programs. This includes overcoming some of these commonly reported barriers in men LWBPC including transportation and distance to the facility, the timing of the program, poor weather, and gender- or disease-specific concerns. To address the current gaps in literature, research is needed to assess the feasibility of a remotely-delivered RT program for cognitive function in men living with and beyond prostate cancer. Accordingly, the primary objective of this study is to assess the feasibility (e.g., enrollment, adherence, attrition, safety, participant satisfaction) of an 8-week supervised, remotely-delivered RT program versus usual care (i.e., exercise guidelines materials) for men LWBPC. The secondary objectives of this study are to examine changes in 1) objective cognitive function; 2) subjective cognitive function; 3) physical function; 4) self-reported exercise; and 5) self-reported fatigue. The trial results may be used to inform a larger randomized controlled trial and demonstrate that a remotely-delivered RT program could be an effective supplementary intervention strategy to mitigate the impact of cancer-related cognitive impairment in men LWBPC.
- Conditions
- Prostate Cancer, Resistance Training
- Being tested
- Resistance Training
- Keywords
- cancer survivorship, cognitive function, prostate cancer, remote delivery, feasibility, 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.
Resistance TrainingBehavioural
The resistance training intervention will consist of two remotely-delivered exercise sessions per week for eight weeks (16 sessions total). One session will be a live, remotely delivered 1:1 class led by a qualified exercise professional (~one hour). The second session will be unsupervised, completed by watching a pre-recorded workout video that will vary bi-weekly to elicit progressive overload. Pre-recorded workout videos will be emailed and feature the qualified exercise professional who will provide instruction to mimic live sessions. Both sessions will involve a dynamic warm-up (~10 minutes), 8 resistance-band exercises (~30-45 minutes), followed by a cool-down (~10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Experimental | The resistance training intervention will consist of two remotely-delivered exercise sessions per week for eight weeks (16 sessions total). One session will be a live, remotely delivered 1:1 class led by a qualified exercise professional (~one hour). The second session will be unsupervised, completed by watching a pre-recorded workout video that will vary bi-weekly to elicit progressive overload. Pre-recorded workout videos will be emailed and feature the qualified exercise professional who will provide instruction to mimic live sessions. Both sessions will involve a dynamic warm-up (~10 minutes), 8 resistance-band exercises (~30-45 minutes), followed by a cool-down (~10 minutes). Receives: Behavioral: Resistance Training |
| Usual Care | No intervention | The usual care group will receive exercise guidelines for cancer survivors (i.e., educational material) from the American College of Sport Medicine. Exercise guidelines materials will be provided through email. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Participant enrollment rate will be one measure of feasibility. Enrollment will be calculated by measuring the number of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Adherence
Participant adherence will be one measure of feasibility. Adherence will be measured by assessing the number of exercise sessions attended divided by the total number of exercise sessions that take place (i.e., 16 sessions). Additionally, adherence to the exercise intensity will be reported by assessing the reported RPE and HR of participants during each session.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Attrition
Attrition will be one measure of feasibility. Attrition will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who completed the entirety of the intervention.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Adverse Events
Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury (e.g., cardiac-related events, musculoskeletal injury or pain, falls) that occurs as a result of the intervention.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Participant Satisfaction
A participant satisfaction survey will be administered following the 8-week intervention to assess the acceptability of the intervention by using researcher-generated statements (e.g., "I found the resistance training intervention rewarding"). The survey will assess the burden of the program and the participant's feedback regarding the RT program and overall study experience. Likert scales ranging from 1 (not at all) to 5 (very much) will be used.
Measured: Post-intervention (8 weeks).
Therapeutic Alliance
Therapeutic alliance will be measured using a modified version of the Working Alliance Inventory Short Revised (WAI-SR). Participants will respond to 12-items of statements and questions about experiences participants might have had with their instructor (e.g., [INSTRUCTOR] and I respect each other]. Participants will rate their responses on a scale from 1 (seldom) to 5 (always). Higher scores indicate better therapeutic alliance.
Measured: Post-intervention (8 weeks).
Secondary outcomes (15)
Objective Cognitive Function
Objective cognitive function will be assessed at baseline and follow-up using the National Institutes of Health (NIH) Toolbox Cognition Battery. The assessment will consist of 5 test instruments: the Picture Sequence Memory Test (episodic memory); the Picture Vocabulary Test (Language-Vocabulary Comprehension); the Oral Reading Recognition Test (Language-Reading Decoding); the List Sorting Working Memory Test (working memory); and the Auditory Verbal Learning Test (working memory). To supplement these tests, the PsyToolkit will be used to deliver the Stroop test (executive function). The cognitive assessments will be delivered remotely via a shared iPad screen and videoconferencing (i.e., Zoom).
Measured: Change from baseline (pre-intervention) to post-intervention (8 weeks).
Subjective Cognitive Function
Subjective cognitive function will be assessed at baseline and follow-up using the Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog v3). This questionnaire will assess cognitive symptoms in the previous 7 days in four domains: perceived impairments, perceived abilities, quality of life, and comments from others. Participants will be asked to rate 37 items related to perceived cognitive complaints on a 5-point Likert scale (0= "not at all" or "never and 4= "very much" or "several times/day) where higher scores indicate fewer cognitive problems and better quality of life.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Physical Function
Physical function will be measured at baseline and follow-up using the remotely-delivered 30-second sit-to-stand test. The purpose of the 30-second sit-to-stand test is to measure participants' lower body strength and endurance by measuring the number of full chair stands with arms folded at the chest completed in 30-seconds. A qualified exercise professional will oversee timing the participant and counting the number of full stands. Higher scores indicate better physical function.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Self-Reported Exercise
Self-reported exercise will be measured using the modified Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants will report the number of times per week and duration that they engage in light, moderate, and vigorous leisure-time exercise, and resistance exercise. Total weekly minutes of MVPA will be calculated as the sum of the number of moderate exercise minutes per week, plus twice the number of vigorous exercise minutes per week. Total RT score will be calculated by summing the number of days spent in RT activities per week.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Self-Reported Fatigue
Fatigue will be assessed at baseline and follow-up using the Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue). The FACIT-Fatigue is a 13-item measure will assess self-reported fatigue and its impact upon daily activities and function. Participants will be asked to rate 13 items related to their fatigue in the previous 7 days on a 5-point Likert scale (0="not at all" or "never" and 4= "very much" or "several times/day) where higher scores indicate higher quality of life.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Anxiety and Depression
Anxiety and depression will be assessed at baseline and post-intervention as an exploratory variable using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item instrument comprised of an anxiety subscale score (HADS-A), a depression subscale score (HADS-D) and a total score (HADS-T), where higher scores indicate higher distress. Each item on the HADS is rated on a 4-point Likert scale, where 0= "not at all" and 3= "yes, definitely".
Measured: Baseline (pre- intervention) and post-intervention (8 weeks).
Clinical Demographics
Clinical variables include: cancer type, date of diagnosis, cancer stage, cancer spread, cancer stage, treatment, current treatment status, recurrences, other cancer diagnoses, general health status, comorbidities, concussion history, smoking history, alcohol consumption history.
Measured: Baseline (pre-intervention)
Age
Demographic variable of age will be assessed. Units of measurement is years.
Measured: Baseline (pre-intervention)
Sex
Demographic variable of biological sex will be assessed. Response options are; male and female.
Measured: Baseline (pre-intervention)
Gender
Demographic variable of gender will be assessed. Response options include; agender, bigender/multigender, gender fluid, genderqueer, man, nonbinary, transgender, two-spirit, woman, and other.
Measured: Baseline (pre-intervention)
Marital Status
Demographic variable of marital status will be assessed. Response options are; single, married, common-law, separated, widowed, and divorced.
Measured: Baseline (pre-intervention)
Highest Level of Education
Demographic variable of highest level of education will be assessed. Response options are; some high school, completed high school, some university/college, completed university/college, some graduate school, completed graduate school.
Measured: Baseline (pre-intervention)
Current Employment Status
Demographic variable of current employment status will be assessed. Response options are; disability, retired, part-time, homemaker, full-time, and unemployed.
Measured: Baseline (pre-intervention)
Ethnicity
Demographic variable of ethnicity will be assessed. Response options are; White, Chinese, South Asian, Black or African American, Latin American, South East Asian (Cambodian, Indonesian, Laotian, Vietnamese), Arab, West Asian (Afghan, Iranian), East Asian (Japanese, Taiwan), and other.
Measured: Baseline (pre-intervention)
Body Mass Index
Demographic variable of body mass index will be assessed. Units of measurement are height (ft.) and weight (lb.). Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)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
- Model description
- Participants will be randomized in a 1:1 ratio to one of two conditions: resistance training intervention or usual care (i.e., exercise guidelines materials). Participants in the resistance training intervention group will receive a remotely-delivered program two days/week for eight weeks (16 sessions total). One session will be 1:1, led by a qualified exercise professional and completed at home via videoconferencing (i.e., Zoom). The second session will be unsupervised, completed by watching a pre-recorded workout video that will vary bi-weekly to elicit progressive overload and mimic live sessions. Participants randomized to the usual care group will receive exercise guidelines for cancer survivors (i.e., educational materials) from the American College of Sport Medicine via email.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Trinh, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828003
- Sponsor's protocol ID
- 47556
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ibeggazene S, Turner R, Rosario D, Bourke L. Remote interventions to improve exercise behaviour in sedentary people living with and beyond cancer: a systematic review and meta-analysis. BMC Cancer. 2021 Mar 24;21(1):308. doi: 10.1186/s12885-021-07989-0.
PubMed 33761906Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):368. doi: 10.1186/s12885-018-4306-9.
PubMed 29614993Norris MK, Bell GJ, North S, Courneya KS. Effects of resistance training frequency on physical functioning and quality of life in prostate cancer survivors: a pilot randomized controlled trial. Prostate Cancer Prostatic Dis. 2015 Sep;18(3):281-7. doi: 10.1038/pcan.2015.28. Epub 2015 Jun 16.
PubMed 26078203Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PubMed 15189396Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
PubMed 23961782Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
PubMed 9095563Amireault S, Godin G, Lacombe J, Sabiston CM. The use of the Godin-Shephard Leisure-Time Physical Activity Questionnaire in oncology research: a systematic review. BMC Med Res Methodol. 2015 Aug 12;15:60. doi: 10.1186/s12874-015-0045-7.
PubMed 26264621Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Bowman A, Denehy L, Benjemaa A, Crowe J, Bruns E, Hall T, Traill A, Edbrooke L. Feasibility and safety of the 30-second sit-to-stand test delivered via telehealth: An observational study. PM R. 2023 Jan;15(1):31-40. doi: 10.1002/pmrj.12783. Epub 2022 Mar 22.
PubMed 35138036Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
PubMed 22613940Von Ah D, Tallman EF. Perceived cognitive function in breast cancer survivors: evaluating relationships with objective cognitive performance and other symptoms using the functional assessment of cancer therapy-cognitive function instrument. J Pain Symptom Manage. 2015 Apr;49(4):697-706. doi: 10.1016/j.jpainsymman.2014.08.012. Epub 2014 Sep 18.
PubMed 25240787Wefel JS, Vardy J, Ahles T, Schagen SB. International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol. 2011 Jul;12(7):703-8. doi: 10.1016/S1470-2045(10)70294-1. Epub 2011 Feb 25.
PubMed 21354373Heaton RK, Akshoomoff N, Tulsky D, Mungas D, Weintraub S, Dikmen S, Beaumont J, Casaletto KB, Conway K, Slotkin J, Gershon R. Reliability and validity of composite scores from the NIH Toolbox Cognition Battery in adults. J Int Neuropsychol Soc. 2014 Jul;20(6):588-98. doi: 10.1017/S1355617714000241. Epub 2014 Jun 24.
PubMed 24960398Thomas T, Althouse A, Sigler L, Arnold R, Chu E, White DB, Rosenzweig M, Smith K, Smith TJ, Schenker Y. Stronger therapeutic alliance is associated with better quality of life among patients with advanced cancer. Psychooncology. 2021 Jul;30(7):1086-1094. doi: 10.1002/pon.5648. Epub 2021 Mar 8.
PubMed 33547717
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06828003
- Acronym / sponsor ID
- 47556
- Conditions
- Prostate Cancer, Resistance Training
- Keywords
- cancer survivorship, cognitive function, prostate cancer, remote delivery, feasibility, resistance training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Feb 2025 (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.
Prostate cancer and its treatment are associated with many long-term adverse effects including cancer-related cognitive impairment. Specifically, androgen deprivation therapy has been shown to negatively impact cognitive function. Combined aerobic and resistance training has been shown to improve cognitive function in men treated with androgen deprivation therapy, but limited research has observed its impact into survivorship. Additionally, existing study designs are limited to supervised, combined aerobic and resistance training interventions. Remotely-delivered resistance training programs could enhance exercise participation by overcoming commonly reported barriers in men living with and beyond prostate cancer such as transportation, distance to facility, and timing of programs. Alongside the needs to address cancer-related cognitive impairments due to androgen deprivation therapy, resistance training may serve to manage functional deficits, losses in bone mineral density and muscle mass and increases in cardiometabolic risk factors. This study will assess the feasibility of an 8-week remotely-delivered resistance training program to improve cognitive function in men living with and beyond prostate cancer who have a history of androgen deprivation therapy treatment.
Detailed description
Prostate cancer and its treatment are associated with many long-term adverse effects including cognitive impairments which have been shown to improve with combined aerobic and resistance exercise. Existing exercise interventions have reported improved cognitive function for men treated with androgen deprivation therapy (ADT). Many of these studies, however, are limited by subjective measures of cognitive function and the use of a generalized quality of life questionnaire to capture cognitive function. Additionally, existing study designs are limited to supervised, combined aerobic and resistance training (RT) interventions. While combined aerobic and RT interventions elicit improvements in cognitive function following ADT, the independent effects of aerobic exercise and RT is less understood. Alongside the needs to address cancer-related cognitive impairments due to ADT, resistance training may serve to manage functional deficits, losses in bone mineral density and muscle mass and increases in cardiometabolic risk factors. There is indirect evidence to support a role for exercise training to attenuate the negative effects of ADT on cognitive function, however, a lack of research has been conducted with men living with and beyond prostate cancer (LWBPC). Given the unique treatment-related impacts on this patient group, there is a need for more adequately powered randomized controlled trials to investigate the direct effects of exercise, and independent effects of RT, on cognitive function in men LWBPC.
Remotely-delivered interventions may be an effective option to increase exercise among men LWBPC, while enhancing reach and accessibility by overcoming barriers to participation in traditional in-person programs. This includes overcoming some of these commonly reported barriers in men LWBPC including transportation and distance to the facility, the timing of the program, poor weather, and gender- or disease-specific concerns. To address the current gaps in literature, research is needed to assess the feasibility of a remotely-delivered RT program for cognitive function in men living with and beyond prostate cancer. Accordingly, the primary objective of this study is to assess the feasibility (e.g., enrollment, adherence, attrition, safety, participant satisfaction) of an 8-week supervised, remotely-delivered RT program versus usual care (i.e., exercise guidelines materials) for men LWBPC. The secondary objectives of this study are to examine changes in 1) objective cognitive function; 2) subjective cognitive function; 3) physical function; 4) self-reported exercise; and 5) self-reported fatigue. The trial results may be used to inform a larger randomized controlled trial and demonstrate that a remotely-delivered RT program could be an effective supplementary intervention strategy to mitigate the impact of cancer-related cognitive impairment in men LWBPC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two conditions: resistance training intervention or usual care (i.e., exercise guidelines materials). Participants in the resistance training intervention group will receive a remotely-delivered program two days/week for eight weeks (16 sessions total). One session will be 1:1, led by a qualified exercise professional and completed at home via videoconferencing (i.e., Zoom). The second session will be unsupervised, completed by watching a pre-recorded workout video that will vary bi-weekly to elicit progressive overload and mimic live sessions. Participants randomized to the usual care group will receive exercise guidelines for cancer survivors (i.e., educational materials) from the American College of Sport Medicine via email.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Experimental | Behavioral: Resistance TrainingThe resistance training intervention will consist of two remotely-delivered exercise sessions per week for eight weeks (16 sessions total). One session will be a live, remotely delivered 1:1 class led by a qualified exercise professional (~one hour). The second session will be unsupervised, completed by watching a pre-recorded workout video that will vary bi-weekly to elicit progressive overload. Pre-recorded workout videos will be emailed and feature the qualified exercise professional who will provide instruction to mimic live sessions. Both sessions will involve a dynamic warm-up (~10 minutes), 8 resistance-band exercises (~30-45 minutes), followed by a cool-down (~10 minutes). |
| Usual Care | No intervention | –The usual care group will receive exercise guidelines for cancer survivors (i.e., educational material) from the American College of Sport Medicine. Exercise guidelines materials will be provided through email. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years of age
- localized or asymptomatic metastatic primary prostate cancer (i.e., androgen receptor axis agents [ARATs] including conventional ADT, abiraterone, enzalutamide)
- a history of ADT treatment
- not currently undergoing radiation
- no neurological or musculoskeletal co-morbidity inhibiting exercise
Key exclusion criteria (6 listed)
- a medical condition that prevents unsupervised exercise
- presence of other primary or recurrent invasive cancer
- have experienced a fall in the last 12 months
- use a gait aid device
- current participation in other exercise programs/trials
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 |
|---|---|---|
| Resistance TrainingThe resistance training intervention will consist of two remotely-delivered exercise sessions per week for eight weeks (16 sessions total). One session will be a live, remotely delivered 1:1 class led by a qualified exercise professional (~one hour). The second session will be unsupervised, completed by watching a pre-recorded workout video that will vary bi-weekly to elicit progressive overload. Pre-recorded workout videos will be emailed and feature the qualified exercise professional who will provide instruction to mimic live sessions. Both sessions will involve a dynamic warm-up (~10 minutes), 8 resistance-band exercises (~30-45 minutes), followed by a cool-down (~10 minutes). | Behavioural | Resistance Training |
Primary outcome
Enrollment
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Participant enrollment rate will be one measure of feasibility. Enrollment will be calculated by measuring the number of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility
Adherence
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Participant adherence will be one measure of feasibility. Adherence will be measured by assessing the number of exercise sessions attended divided by the total number of exercise sessions that take place (i.e., 16 sessions). Additionally, adherence to the exercise intensity will be reported by assessing the reported RPE and HR of participants during each session.
Attrition
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Attrition will be one measure of feasibility. Attrition will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who completed the entirety of the intervention.
Adverse Events
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury (e.g., cardiac-related events, musculoskeletal injury or pain, falls) that occurs as a result of the intervention.
Participant Satisfaction
Time frame: Post-intervention (8 weeks).
A participant satisfaction survey will be administered following the 8-week intervention to assess the acceptability of the intervention by using researcher-generated statements (e.g., "I found the resistance training intervention rewarding"). The survey will assess the burden of the program and the participant's feedback regarding the RT program and overall study experience. Likert scales ranging from 1 (not at all) to 5 (very much) will be used.
Therapeutic Alliance
Time frame: Post-intervention (8 weeks).
Therapeutic alliance will be measured using a modified version of the Working Alliance Inventory Short Revised (WAI-SR). Participants will respond to 12-items of statements and questions about experiences participants might have had with their instructor (e.g., [INSTRUCTOR] and I respect each other]. Participants will rate their responses on a scale from 1 (seldom) to 5 (always). Higher scores indicate better therapeutic alliance.
15 secondary outcomes
Objective Cognitive Function
Time frame: Change from baseline (pre-intervention) to post-intervention (8 weeks).
Subjective Cognitive Function
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Physical Function
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Self-Reported Exercise
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Self-Reported Fatigue
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Anxiety and Depression
Time frame: Baseline (pre- intervention) and post-intervention (8 weeks).
Clinical Demographics
Time frame: Baseline (pre-intervention)
Age
Time frame: Baseline (pre-intervention)
Sex
Time frame: Baseline (pre-intervention)
Gender
Time frame: Baseline (pre-intervention)
Marital Status
Time frame: Baseline (pre-intervention)
Highest Level of Education
Time frame: Baseline (pre-intervention)
Current Employment Status
Time frame: Baseline (pre-intervention)
Ethnicity
Time frame: Baseline (pre-intervention)
Body Mass Index
Time frame: Baseline (pre-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 33761906Ibeggazene S, Turner R, Rosario D, Bourke L. Remote interventions to improve exercise behaviour in sedentary people living with and beyond cancer: a systematic review and meta-analysis. BMC Cancer. 2021 Mar 24;21(1):308. doi: 10.1186/s12885-021-07989-0.
- Background: PubMed 29614993Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):368. doi: 10.1186/s12885-018-4306-9.
- Background: PubMed 26078203Norris MK, Bell GJ, North S, Courneya KS. Effects of resistance training frequency on physical functioning and quality of life in prostate cancer survivors: a pilot randomized controlled trial. Prostate Cancer Prostatic Dis. 2015 Sep;18(3):281-7. doi: 10.1038/pcan.2015.28. Epub 2015 Jun 16.
- Background: PubMed 15189396Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
- Background: PubMed 23961782Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 9095563Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Background: PubMed 26264621Amireault S, Godin G, Lacombe J, Sabiston CM. The use of the Godin-Shephard Leisure-Time Physical Activity Questionnaire in oncology research: a systematic review. BMC Med Res Methodol. 2015 Aug 12;15:60. doi: 10.1186/s12874-015-0045-7.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Background: PubMed 35138036Bowman A, Denehy L, Benjemaa A, Crowe J, Bruns E, Hall T, Traill A, Edbrooke L. Feasibility and safety of the 30-second sit-to-stand test delivered via telehealth: An observational study. PM R. 2023 Jan;15(1):31-40. doi: 10.1002/pmrj.12783. Epub 2022 Mar 22.
- Background: PubMed 22613940Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
- Background: PubMed 25240787Von Ah D, Tallman EF. Perceived cognitive function in breast cancer survivors: evaluating relationships with objective cognitive performance and other symptoms using the functional assessment of cancer therapy-cognitive function instrument. J Pain Symptom Manage. 2015 Apr;49(4):697-706. doi: 10.1016/j.jpainsymman.2014.08.012. Epub 2014 Sep 18.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Prostate Cancer and Resistance Training, 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 10 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).). The study lists 6 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 NCT06828003, which also lists 37 linked publications.
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 14 Feb 2025.