NCT01749774已完成不适用
Physical Activity and Testicular Cancer - a Pilot Study: Feasibility and Effects of a Program Including Information, Counseling and a Physical Activity Program for Patients With Testicular Cancer During and After Chemotherapy
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Muscle strength, 1RM (one-repetition-maximum)
研究概览
简要总结
The purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. It is hypothesized that the patients are able to complete the intervention with individual adjustments.
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
- •Seminoma/non-seminoma
- •Stage II-IV
- •3-4 BEP(bleomycin,etoposide and cisplatin)or 4 EP(etoposide and cisplatin)
- •> 18 years
- •Capable of reading and writing Norwegian
排除标准
- •Conditions of a severity that contraindicate exercise without adjusted actions
- •Mentally incompetent conditions
- •Conditions of a severity that complicates the ability to participate in a supervised training program
结局指标
主要结局
Muscle strength, 1RM (one-repetition-maximum)
时间窗: Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)
Change in 1RM from baseline to post-intervention and follow-up
次要结局
- Cardio respiratory fitness (VO2max)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Metabolic disease markers (blood pressure, body mass index, glucose, high density lipoprotein cholesterol, triglycerides)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Body composition (Lean body mass and fat mass)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Work status(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Myoglobin(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- C-reactive protein (CRP)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Creatinkinase (CK)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Anxiety and depression(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Quality of life(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Creatinkinase - MB (CK-MB)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
- Fatigue(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
研究者
Lene Thorsen
PhD
Oslo University Hospital
研究点 (1)
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