Exercise for Fighting Oncology Repercussions After Treatment: the EFFORT Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
Cancer survival rates are currently on the verge of 70% at 5 years since diagnosis. Recent improvements in main cancer therapies including chemotherapy, radiotherapy, surgery and immunotherapy as well as developments of new biological therapies have significantly improved survival rates but unfortunately, cancer-related side effects continue to affect many patients even years after completion of main treatments. Exercise has been shown to not only ameliorate cancer-related effects before, during and after treatment but also improve disease-free and overall survival rates by decreasing risk factors associated with cancer risk and improving resilience to treatment. In this non-randomised, three-arm study, we aim to assess the effects of three forms of exercise (i.e: Nordic Walking, Aquatic Exercise and Functional Exercise) on physical performance, cancer-related fatigue, health-related quality of life and cancer-specific symptoms in a wide range of cancer survivors.
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
- •Adults diagnosed with cancer
- •Completion of any cancer therapy in the previous 3 months with the exception of hormonal therapy
- •Patients living within the Maresme Area
- •No contraindications for exercise (oncology clearance or Physical Activity Readiness Questionnaire negative)
排除标准
- •Patients with any neurologic, cognitive or musculoskeletal impairments that prevent them to engage in any assessment test or exercise modality.
- •Patients with unstable cardiac, respiratory or metabolic diseases
- •Unable to speak or read Catalan or Spanish
研究组 & 干预措施
Nordic Walking
Patients in this arm will be assigned to a 12-week exercise intervention twice weekly based on Nordic Walking (NW). The intervention will be structured as follows: i) 10 min warm-up, ii) 40 min NW with muscle strengthening exercises interspersed in between and iii) 10 min cool-down. Intensity will be monitored with a heart rate monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) to a moderate-to-high intensity the following weeks (7 - 8 or 65-75% HR reserve).
干预措施: Nordic Walking (Behavioral)
Aquatic Exercise
Patients in this group will be assigned to a 12-week, twice weekly water-based exercise programme to be conducted at a chest-high swimming pool kept around 30 to 32 degrees Celsius. Each session will be structured as previous: i) 10 min warm up; ii) 40 min of combined endurance and strength exercise training and iii) 10 min cool down. Intensity will be monitored using the Borg Scale to be moderate during the first 6 weeks (4 - 6) and moderate-to-high the following 6 weeks (7-8).
干预措施: Aquatic Exercise (Behavioral)
Functional Exercise Training
In this group, patients will participate in a traditional, circuit-based exercise training at a fitness facility twice daily during 12 weeks. Each session will consist of: i) 10 min warm up; ii) 40 min of combined resistance and endurance training using a circuit-based structure and iii) 10 min cool-down. Intensity will be monitored with a HR monitor (when available) and/or Borg Scale to reach a moderate intensity for the first 6 weeks (4 - 6 or 55-65% HR reserve) and will progress to moderate-to-high over the following weeks (7-8 or 65-75% HR reserve).
干预措施: Functional Exercise Training (Behavioral)
结局指标
主要结局
Health-Related Quality of Life
时间窗: 12 weeks from baseline
HRQoL measured with the EORTC Quality of Life C30 questionnaire
次要结局
- Estimated one-repetition maximum(12 weeks from baseline)
- Lower limb muscle endurance(12 weeks from baseline)
- Functional capacity(12 weeks from baseline)
- Cancer-related fatigue(12 weeks from baseline)
- Cardiorespiratory fitness(12 weeks from baseline)
研究者
Raquel Sebio
Senior Lecturer
Universitat Pompeu Fabra