Feasibility and Acceptance of High Intensity Interval Training in the Prehabilitation of Patients Suffering From Gynecological Cancers - a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- adherence to the exercise intervention
研究概览
简要总结
In 2016, 2216 Austrian women (= 10% of all new cancer cases) were diagnosed with gynecological tumors. Depending on stage and entity, a main primary therapy option is the surgical tumor resection. In the phase of Prehabilitation (= the time frame from diagnosis to surgical intervention) supportive therapy options such as individualized exercise interventions potentially improve recovery and postoperative outcomes after surgical interventions. The primary aim of this study is to investigate the feasibility and acceptance of a prehabilitation training intervention with high-intensity interval training compared to a conventional moderate intensity continuous training and a non-training collective. Secondary goals are the investigation of the effectiveness of threshold-based intensity prescriptions and the impact on quality of life, fatigue, anxiety, depression, sexuality and ability to work.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histopathologically verified cervical carcinoma (ICD10-C53) or
- •endometrial carcinoma (ICD10-C54) or
- •ovarian carcinoma (ICD10-C56)
- •planned primary/adjuvant surgery or medical training therapy
- •oncological release for medical training therapy
- •Eastern cooperative oncology group performance status (ECOG) 0-II
- •Age >18a to 80
- •mental aptitude to participate in the study
排除标准
- •serious orthopaedic, rheumatological, neurological, oncological and cardiovascular diseases which are incompatible with a training intervention
- •general contraindications for exercise ergometry according to the guidelines of the austrian society of cardiology
- •osseous or cerebral metastasis
- •participation in a training study in the last year or already before cancer diagnosis with high training volumes (>150min moderate / >75min more intensive endurance training per week)
结局指标
主要结局
adherence to the exercise intervention
时间窗: 4 to 8 weeks
rate of completed exercise sessions as a measure of feasibility and acceptance
次要结局
- cardiovascular fitness(4 to 8 Weeks)
- workability(4 to 8 weeks)
- Health related Quality of life: questionnaire(4 to 8 weeks)
- Anxiety and depression(4 to 8 weeks)
- handgrip strength(4 to 8 weeks)
- body composition(4 to 8 weeks)
- Thyreoglobulin(4 to 8 weeks)
- hemoglobin A1c(4 to 8 weeks)
- Cholesterol(4 to 8 weeks)
- Brain natriuretic peptide(4 to 8 weeks)
- interleukin 6(4 to 8 weeks)
- Troponin T(4 to 8 weeks)
- Creatin Kinase(4 to 8 weeks)
- C-reactive protein(4 to 8 weeks)
- interleukin 1(4 to 8 Weeks)
- Tumor Necrosis Factor alpha(4 to 8 weeks)
研究者
Stefano Palma
Principal Investigator, PhD student
Medical University of Vienna