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

Официальное название

A Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer: A Feasibility Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Objective Cognitive Function [Срок оценки: Change from baseline (pre-intervention) to post-intervention (8 weeks).]
• Subjective Cognitive Function [Срок оценки: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Physical Function [Срок оценки: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Self-Reported Exercise [Срок оценки: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Self-Reported Fatigue [Срок оценки: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Anxiety and Depression [Срок оценки: Baseline (pre- intervention) and post-intervention (8 weeks).]
• Clinical Demographics [Срок оценки: Baseline (pre-intervention)]
• Age [Срок оценки: Baseline (pre-intervention)]
• Sex [Срок оценки: Baseline (pre-intervention)]
• Gender [Срок оценки: Baseline (pre-intervention)]
• Marital Status [Срок оценки: Baseline (pre-intervention)]
• Highest Level of Education [Срок оценки: Baseline (pre-intervention)]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• University of Toronto — Toronto

Публикации

• 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
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Идентификаторы

NCT: NCT06828003 · 47556

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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