Clinical trial NCT06828003: Feasibility of a Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer
Official title: A Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Resistance Training
Keywords: cancer survivorship
cognitive function
prostate cancer
remote delivery
feasibility
resistance training
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* ≥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 \[scores between 21-24 to separate individuals with mild cognitive impairment and normal cognition (\>24)\]
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Enrollment
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Adherence
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Attrition
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Adverse Events
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Participant Satisfaction
timeFrame: Post-intervention (8 weeks).
measure: Therapeutic Alliance
timeFrame: Post-intervention (8 weeks).
Secondary outcomes:
measure: Objective Cognitive Function
timeFrame: Change from baseline (pre-intervention) to post-intervention (8 weeks).
measure: Subjective Cognitive Function
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Physical Function
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Self-Reported Exercise
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Self-Reported Fatigue
timeFrame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
measure: Anxiety and Depression
timeFrame: Baseline (pre- intervention) and post-intervention (8 weeks).
measure: Clinical Demographics
timeFrame: Baseline (pre-intervention)
measure: Age
timeFrame: Baseline (pre-intervention)
measure: Sex
timeFrame: Baseline (pre-intervention)
measure: Gender
timeFrame: Baseline (pre-intervention)
measure: Marital Status
timeFrame: Baseline (pre-intervention)
measure: Highest Level of Education
timeFrame: Baseline (pre-intervention)
measure: Current Employment Status
timeFrame: Baseline (pre-intervention)
measure: Ethnicity
timeFrame: Baseline (pre-intervention)
measure: Body Mass Index
timeFrame: Baseline (pre-intervention)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
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