Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
研究概览
简要总结
In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with feelings of anxiety and depression associated with the disease and associated treatments. Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this population, but the impact of single bouts of exercise and related psychological or neurological changes have never been studied. The primary objective of the proposed study is to examine the effect of an acute bout of exercise on neurophysiological and psychological indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa. Participants will be randomly assigned to the intervention (60 min exercise) or control (60 min of television) and will undergo a brief neurological test (cortical silent period) and psychological questionnaires before and after their group assignment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed PCa;
- •> 6 months post curative therapy for PCa (radical prostatectomy or radiation therapy) with or without adjuvant androgen deprivation therapy;
- •Willing and able to provide informed consent;
- •If metastatic disease is present, they are asymptomatic; v) n
- •No contraindications to exercise
排除标准
- •Severe coronary artery disease (Canadian Cardiovascular Society class III or greater);
- •Significant congestive heart failure (New York Heart Association class III or greater);
- •Uncontrolled pain;
- •Neurological or musculoskeletal co-morbidity inhibiting exercise;
- •Diagnosed psychotic, addictive, or major cognitive disorders or are currently or have a history of using psychotropic medication (anti-depressants, anti-anxiety, anti-psychotics, benzodiazepines, etc);
- •Contraindications to magnetic exposure (surgical clips in the brain; cardiac pace maker or valves; cochlear implants; metal rods, plates, screws in head; shrapnel/metal fragments in head/eyes; dentures);
- •Prior history of seizures or diagnosis of epilepsy;
- •Left-hand dominant; and
- •No more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine[41, 42]:
- •Family history of coronary disease, cigarette smoking, hypertension (Systolic Blood Pressure (SBP) > 140 mmHg; Diastolic Blood Pressure (DBP) > 90 mmHg), known dyslipidemia, known impaired fasting, glucose (>110 mg/dL), obesity (BMI > 30 kg/m2 or waist circumference > 102cm), or physically inactive (<150 min of moderate intensity physical activity per week)
结局指标
主要结局
Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.
时间窗: 10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').
CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.
次要结局
- Profile of Mood States Questionnaire(PoMS)(10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)
- State-Trait Anxiety Inventory - Questionnaire(STAI)(10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)
- Hospital Anxiety and Depression Scale - Questionnaire(HADS)(10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)
- Exercise-Induced Feelings Inventory - Questionnaire (EIFI)(10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)
研究者
Daniel Santa Mina
Assistant Program Head, Kinesiology
University of Guelph-Humber