Differentiated Resistance Training of the Paravertebral Muscles in Patients With Unstable Spinal Bone Metastasis Under Concomitant Radiotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- feasibility of isometric exercise in unstable vertebral bony metastases
研究概览
简要总结
Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures.
Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support Radiation therapy and improve above named factors. DISPO-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful unstable bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.
详细描述
Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO-2 was designed to investigate the impact of tailored physical exercise in patients with unstable vertebral metastases as compared to manual therapy (progressive muscle relaxation). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.
Patients are randomized to one of the following groups: patients in arm A carry out daily physical training consisting of four different isometric exercises under the guidance and supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10 daily units of 30 min each are scheduled during radiotherapy. Patients are expected to continue training until 12 weeks post completion of radiotherapy at home. Patients in arm B (control group) receive 10 daily sessions of 15 min progressive muscle relaxation starting from day one of radiotherapy. Follow-up of the patients is scheduled at 12 weeks post completion of radiotherapy incl. CT of the spine and physical examination.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •solitary or multiple vertebral metastases
- •thoracic spine
- •lumbar spine
- •indication for palliative radiation therapy
- •age: 18 - 80 years
- •Karnofsky index > 70%
- •bisphosphonate therapy initiated
排除标准
- •bony metastases of cervical spine or pelvis
- •impending fracture
- •other serious illnesses or medical conditions: therapy-refractory unstable heart disease, congestive heart failure NYHA °III and °IV; coagulopathies
- •Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
- •Legal incapacity or limited legal capacity
- •Positive serum/ urine beta-HCG/ pregnancy
结局指标
主要结局
feasibility of isometric exercise in unstable vertebral bony metastases
时间窗: 12 weeks post completion of radiotherapy
completion of all isometric exercises until 12 weeks post RT
次要结局
- progression-free survival (PFS)(2 years post completion of radiotherapy)
- pain reduction(Immediately after completion of radiotherapy, 12 and 24 weeks post completion of radiotherapy)
- bone density(12 weeks post completion radiotherapy)
- Quality of life(12 and 24 weeks post completion of therapy)
- fracture-free survival (FFS)(2 years post completion of radiotherapy)
- Fatigue(12 and 24 weeks post completion of therapy)