Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in fatigue
研究概览
简要总结
The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy.
A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer;
- •age over 18 years;
- •no distant metastases and/or disease progression;
- •at least 25 scheduled radiation treatments (5 weeks);
- •ability to read, write, and speak French.
排除标准
- •uncontrolled cardiac, hypertensive or pulmonary diseases,
- •uncontrolled insulin-dependent diabetes mellitus,
- •neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation
- •abnormal electrocardiogram.
结局指标
主要结局
Change in fatigue
时间窗: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Fatigue is measured by FACIT-fatigue questionnaire
次要结局
- Change in functional capacity(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Change in quality of life(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Change in sleep disturbances(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Change in somnolence syndrome(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Change in insomnia(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Change in depression symptoms(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Change in executive functions(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Change in dyspnea(Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer))
- Adherence(Weekly through the intervention (during 8 weeks))
研究者
Caty Gilles
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain