Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Feasibility - Adherence rate to the exercise program
研究概览
简要总结
Prostate cancer (PCa) is among the most widespread in the male population and represents 19% of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT) and Radiotherapy (RT) are used for increase survival. However, both therapies are associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline that together lead to an increase risk of accidental falls and fractures.
Guidelines for cancer survivors recommend Physical Exercise (PE) as a strategy to reduce several side effects of therapies. However, most people living with cancer do not meet current exercise recommendations.
Indeed, an effective PE program requires the application of long-term, moderate to high intensity activity. Thus it may be difficult to implement this type of recommendation in patient with PCa.
Therefore, this study aims to develop an experimental PE intervention testing their feasibility and safety and the patients' satisfaction, aimed at improving the health conditions of the patients with PCa receiving ADT and RT. Furthermore, long-term falls and fracture events will be monitored.
详细描述
The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of a structured, multicomponent, supervised and unsupervised exercise program.
Secondary outcome will be evaluate the change in the health condition, in particular muscle strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of life.
The PE program will be conducted at the "Virgilio Camparada" Municipal Athletic Track in the city of Reggio Emilia (IT). Patients will be participate in a supervised exercise program with three sessions per week, for eight weeks. Subsequently, the intervention will continue further for four weeks maintaining one supervised session and two unsupervised sessions a week. Finally, sessions will be performed without supervision for further eight weeks. The overall duration of the intervention will be twenty weeks. In addition, an evaluation will be performed at one year from baseline to monitor long-term fall and fracture events.
At baseline will be the following assessment:
- clinical and anthropometric data and the Six Minute Walking Test (6MWT) to determine the intensity of aerobic exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Histologically documented diagnosis of PCa;
- •Undergo ADT and RT during the study period;
- •At least 18 years old;
- •Willing and able to give written informed consent;
- •Able to read and understand Italian Language;
排除标准
- •Musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.
结局指标
主要结局
Feasibility - Adherence rate to the exercise program
时间窗: Throughout the 20 week study period
Determine the percentage of patients adhering to the program and the weekly exercise sessions.
Feasibility - Recruitment rate
时间窗: At baseline (T0)
Percentage ratio between patients included in the study and number of participants screened for recruitment.
Feasibility - Dropout rate
时间窗: Throughout the 20 week study period
Percentage of patients that withdraw from the study and the reason to withdraw
Feasibility - Safety/Adverse events
时间窗: Throughout the 20 week study period
Any adverse events, related or not related to the exercise program, will be documented
Feasibility - Compliance and patients' experience
时间窗: Following the study conclusion at 20 weeks.
Determined by qualitative evaluation, using interviews, to assess experiences, accessibility and acceptability of the exercise intervention.
次要结局
- Change of muscular strength assessment(At baseline and 20 weeks.)
- Change of fatigue assessment(At baseline and 20 weeks.)
- Falls and fractures.(Throughout the 20 week study period and at one year of follow-up.)
- Change of cognitive status assessment(At baseline and 20 weeks.)
- Change of fall risk assessment(At baseline and 20 weeks.)
- Change of anxiety and depression level(At baseline and 20 weeks.)
- Change of quality of life assessment(At baseline and 20 weeks.)