Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- adherence to the group exercise programme
研究概览
简要总结
The aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view.
详细描述
The intervention will consist of EFG sessions lasting 45 minutes each, twice a week for 12 weeks to be carried out in the gym of the Rehabilitation Day Hospital.
Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises, and will be led by a physiotherapist. The exercises proposed to the group with ECOG 2 will be less intense and of less difficulty with the aim of adapting the activity to patients with a lower performance status (see appendix 4.5, V2, 07/10/2024). The groups will consist of a minimum of five patients and a maximum of ten. Patients will also be stimulated to perform physical activity at home to a total of 150 minutes per week. Patients will be assessed at baseline (T0), at the end of the intervention (T1,12 weeks) and 6 months after the start of the intervention (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •neoplastic tumor
- •age>= 18
- •prognosis> 12 months
- •ECOG <=2
- •Walking with/ without aids
- •clinically stable
- •signed informed consent
- •Patients with bone metastases with ECOG from 0-1 suitable results
排除标准
- •sensory deficits who cannot perform physical exercise
- •cognitive impairment that compromises collaboration and questionnaire filling
- •patients with pathologies (e.g. neurological, psychiatric) that do not allow the obtaining of valid informed consent
研究组 & 干预措施
ECOG 0-1
Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises and will be led by a physiotherapist
干预措施: exercise programme for group with ECOG 0-1 (Procedure)
ECOG 2
The exercises proposed to the group with ECOG 2 will be less intense and less difficult with the aim of adapting the activity to patients with a lower performance status
干预措施: exercise programme for ECOG 2 group (Procedure)
结局指标
主要结局
adherence to the group exercise programme
时间窗: through study completion, an average of 2 years
overall adherence to the group exercise programme \> 40%
Frequency
时间窗: through study completion, an average of 2 years
The frequency of at least 70% of the exercise sessions foreseen by the programme.
次要结局
- QoL(through study completion, an average of 2 years)
- tolerance to effort(through study completion, an average of 2 years)