Feasibility of a Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resistance Training

    Behavioral

    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).

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Resistance TrainingExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).
2

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.

Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).
3

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.

Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).
4

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.

Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).

Secondary outcomes

1

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).

Time frame
Change from baseline (pre-intervention) to post-intervention (8 weeks).
2

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.

Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).
3

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.

Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).
4

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.

Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).

Other outcomes

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