SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change of quality of life assessed with EPIC26 (0-100 points)
研究概览
简要总结
The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question[s] it aims to answer are:
- What is the impact of exercise on quality of life
- What is the impact of exercise on physical fitness
Participants will have an individual training program with supervised training by physiotherapists.
Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age > 18 years old
- •Able to read and complete questionnaires in Dutch
- •Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)
排除标准
- •Other cancers
- •Clinicians' judgement
- •Age >80 years old or not able to walk 400m
- •Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months
- •Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising
- •Spinal cord compression, history of pathological fractures
结局指标
主要结局
change of quality of life assessed with EPIC26 (0-100 points)
时间窗: 3 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
时间窗: 3 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.
change of quality of life assessed with EPIC26 (0-100 points)
时间窗: 6 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
时间窗: 6 months
To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.
次要结局
- change of physical fitness in fat percentage(6 months)
- change of physical fitness in maximum uptake of oxygen in ml/kg/min(3 months)
- change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))(6 months)
- change of physical fitness in maximum uptake of oxygen in ml/kg/min(6 months)
- change of physical fitness in fat percentage(3 months)
- change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))(3 months)