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

Overview

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.

Interventions

• Behavioral Resistance Training
  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 wil

Primary outcome measures

• Enrollment [Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Adherence [Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Attrition [Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Adverse Events [Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Participant Satisfaction [Time frame: Post-intervention (8 weeks).]
• Therapeutic Alliance [Time frame: Post-intervention (8 weeks).]

Secondary outcome measures (12)

• 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Canada · 1 center

• University of Toronto — Toronto

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. PMID 33761906
• Dawson 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. PMID 29614993
• Norris 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. PMID 26078203
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• Yellen 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. PMID 9095563
• Amireault 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. PMID 26264621

Identifiers

NCT: NCT06828003 · 47556

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗