A Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living with and Beyond Prostate Cancer: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participants will only be aware that the researchers are comparing the two conditions, and therefore will be blinded to the study hypotheses.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
结局指标
主要结局
Enrollment
时间窗: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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
Attrition
时间窗: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Adherence
时间窗: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Adverse Events
时间窗: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Participant Satisfaction
时间窗: Post-intervention (8 weeks).
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.
Therapeutic Alliance
时间窗: Post-intervention (8 weeks).
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.
次要结局
- Subjective Cognitive Function(Change from baseline (pre- intervention) to post-intervention (8 weeks).)
- Clinical Demographics(Baseline (pre-intervention))
- Self-Reported Exercise(Change from baseline (pre- intervention) to post-intervention (8 weeks).)
- Objective Cognitive Function(Change from baseline (pre-intervention) to post-intervention (8 weeks).)
- Self-Reported Fatigue(Change from baseline (pre- intervention) to post-intervention (8 weeks).)
- Age(Baseline (pre-intervention))
- Physical Function(Change from baseline (pre- intervention) to post-intervention (8 weeks).)
- Anxiety and Depression(Baseline (pre- intervention) and post-intervention (8 weeks).)
- Sex(Baseline (pre-intervention))
- Gender(Baseline (pre-intervention))
- Marital Status(Baseline (pre-intervention))
- Highest Level of Education(Baseline (pre-intervention))
- Current Employment Status(Baseline (pre-intervention))
- Ethnicity(Baseline (pre-intervention))
- Body Mass Index(Baseline (pre-intervention))
研究者
Linda Trinh
Associate Professor
University of Toronto
