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

NCT06828003 | Not Yet Recruiting

• 1 other identifier: 47556
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Resistance Training

Keywords

cancer survivorship; cognitive function; prostate cancer; remote delivery; feasibility; resistance training

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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.

  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.

  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.

  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.

  Post-intervention (8 weeks).

Secondary Outcomes (15)

• Objective Cognitive Function

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

• Subjective Cognitive Function

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

• Physical Function

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

• Self-Reported Exercise

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

• Self-Reported Fatigue

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

Study Arms (2)

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).

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.

Interventions

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).

Resistance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S2W6, Canada

Location

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will only be aware that the researchers are comparing the two conditions, and therefore will be blinded to the study hypotheses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)